ObesityPhase 3STEP UPNCT05646706
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
A Phase 3 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 107 sites in 12 countries.
Trial summary
This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,407 participants
- Where
- 107 sitesin 12 countries
- Study dates
- 4 Jan 2023to 26 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Who cannot join
- HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Trial locations and contacts
107 sites in 12 countries.
107 sites in 12 countries
United States21 sites
AMC Community Endocrinology
Albany, New York, 12203
Amarillo Med Spec LLP
Amarillo, Texas, 79106
Elligo Clin Res Centre
Austin, Texas, 78704
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 27514
Medical University Of South Carolina
Charleston, South Carolina, 29425
Velocity Clin Res, Dallas
Dallas, Texas, 75230
UT Southwestern Medical Center-CRU
Dallas, Texas, 75390
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
East West Med Res Inst
Honolulu, Hawaii, 96814
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
DCOL Ctr for Clin Res
Longview, Texas, 75605
Chambliss Clinical Trials, LLC
Montgomery, Alabama, 36106
Healthscan Clinical Trials,LLC.
Montgomery, Alabama, 36106
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
Florida Institute For Clinical Research LLC
Orlando, Florida, 32825
National Clin Res Inc.
Richmond, Virginia, 23294
Sugar Lakes Family Practice PA
Sugar Land, Texas, 77479
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Selma Medical Associates
Winchester, Virginia, 22601-3834
Bulgaria10 sites
Medical centre Zdrave 1 OOD
Kozloduy, 3320
Medical center Hippocrates Lukovit EOOD
Lukovit, 5770
IPMC - Dr. Elizabeta Dimitrova
Petrich, 2850
Medical center Smolyan clinical research OOD
Smolyan, 4700
DCC Ascendent OOD
Sofia, 1202
SGHAT Dr. Shterev EOOD
Sofia, 1330
Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology
Sofia, 1407
Medical Centre Medical Arts Medico-dental centre
Sofia, 1618
Medical Center Medical Plus EOOD
Varna, 9000
AIPSMC Dr. Evelina Zlatanova EOOD
Varna, 9010
Germany10 sites
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910
InnoDiab Forschung GmbH
Essen, 45136
Praxis Dr. med. M. Esser
Essen, 45219
Zentrum für klinische Forschung, Dr. med. Lüdemann
Falkensee, 14612
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, 48153
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, 66780
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239
Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
Witten, 58455
South Africa10 sites
Medi-Clinic Bloemfontein
Bloemfontein, Free State, 9301
Precise Clinical Solutions (Pty) Ltd
Durban, KwaZulu-Natal, 4092
Dr N.K. Gounden Medical Centre
Durban, KwaZulu-Natal, 4093
Lenmed Shifa Private Hospital
Durban, KwaZulu-Natal, 4901
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, 4170
Soweto Clinical Trial Centre
Johannesburg, Gauteng, 1818
Deepak Lakha
Johannesburg, Gauteng, 1820
Hemant Makan
Johannesburg, Gauteng, 1827
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, 2013
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001
Greece9 sites
University Hospital of Athens ATTIKON
Athens, Attica, 12462
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
Athens, 11527
Iatriko Athinon (Athens Medical Canter)
Athens, 15125
Iatriko Athinon 'Palaiou Falirou'
Athens, 17562
General Hospital of Lamia
Lamia, 35100
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, 54635
AHEPA General University Hospital
Thessaloniki, 54636
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, 54642
"Thermi" Private Hosital
Thessaloniki, 57001
Canada8 sites
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V7
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 1V7
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8L 5G4
Wharton Med Clin Trials
Hamilton, Ontario, L8L 5G8
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, L8L 5G8
Hamilton Med Res Group
Hamilton, Ontario, L8M 1K7
Milestone Research
London, Ontario, N5W 6A2
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6
Poland8 sites
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, 15-481
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, 81-338
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
Katowice, 40-752
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, 20-538
NZOZ "CenterMed Lublin" Sp. z o.o.
Lublin, Lublin Voivodeship, 20-044
NBR Polska Tomasz Klodawski
Warsaw, 00-710
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
Slovakia8 sites
MUDr. Dagmar Prokesova, Endokrinologicka ambulancia
Bratislava, 821 01
MEDIMAD, s.r.o., Endokrinologicka ambulancia
Bratislava, 842 31
IN-DIA s.r.o.
Lučenec, 984 01
SIN AZUCAR s.r.o.
Malacky, 901 01
MED-CENTRUM, s.r.o.
Martin, 036 01
SVAJDLEROVA, s.r.o.
Prešov, 080 01
MEDIVASA, s.r.o., Angiologicka ambulancia
Žilina, 010 01
Dom srdca, s.r.o.
Žilina, 01001
Czechia7 sites
Ordinace praktického lékaře
Benátky Na Jizerou, 29471
Edumed Broumov
Broumov, 550 01
Fakultní nemocnice Královské Vinohrady_Praha 10
Prague, 10034
Endocare
Prague, 140 00
Institut klinické a experimentalni mediciny
Prague, 14021
Poliklinika Michnova - Obezitologie
Prague, 149 00
Fledip s.r.o.
Prague, 160 00
Hungary7 sites
Lausmed Kft.
Baja, Bács-Kiskun county, 6500
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1089
Bajcsy-Zsilinszky Kórház
Budapest, 1106
MED-TIMA Kft.
Budapest, 1132
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405
Fejér Megyei Szent György Oktatókórház
Székesfehérvár, 8000
Portugal6 sites
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-230
Unidade Local De Saúde De Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, 1349-019
Hospital da Luz Lisboa, S.A.
Lisbon, 1500-650
ULS De São João, E.P.E. - Hospital de São João
Porto, 4200-319
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, 4464-513
Hospital da Luz Arrabida, S.A.
Vila Nova de Gaia, 4400-346
Norway3 sites
Falck Norge AS
Hamar, 2317
Oslo universitetssykehus HF Aker
Oslo, 0373
Sykehuset i Vestfold HF, Tønsberg
Tønsberg, 3116
About this study
Official title: Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
- Conditions
- Obesity
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
SemaglutideDrug
Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
PlaceboDrug
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 7.2 mg | Experimental | Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72. Receives: Drug: Semaglutide |
| Semaglutide 2.4 mg | Experimental | Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Number of participants who achieve body weight reduction >=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=5% and "no" defines participants who did not achieve body weight reduction >=5%.
Measured: At week 72
Secondary outcomes (44)
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)
Number of participants who achieve body weight reduction >=10% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=10% and "no" defines participants who did not achieve body weight reduction >=10%.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)
Number of participants who achieve body weight reduction >=15% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=15% and "no" defines participants who did not achieve body weight reduction >=15%.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%.
Measured: At week 72
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight
Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)
Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)
Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)
Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)
Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)
Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)
Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (%)
Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)
Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline
Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline
Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline
Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline
Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline
Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Change in hsCRP (milligram per liter [mg/L]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.
Measured: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5%
Measured: Baseline (week 0), end of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Measured: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Measured: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Placebo: Change in Pulse
Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.
Measured: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs
Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.
Measured: From baseline (week 0) to end of study (week 81)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs
Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.
Measured: From baseline (week 0) to end of study (week 81)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start4 Jan 2023
- Primary completion30 Oct 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646706
- Sponsor's protocol ID
- NN9536-4999
- Other IDs
- U1111-1274-4259, 2022-000790-94
- Acronym
- STEP UP
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2022
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Publications
Hjelmesaeth J, Bhat S, Garvey WT, Kolnes KJ, Linge J, Lingvay I, Rasmussen NK, Rosenstock J, Wharton S. Effect of Semaglutide on Thigh Skeletal Muscle Volume, Fat Infiltration and Physical Function in People With Obesity: Secondary Analysis of STEP UP. Diabetes Obes Metab. 2026 Sep 20. doi: 10.1111/dom.71323. Online ahead of print.
PubMed 42764399Wharton S, Freitas P, Hjelmesaeth J, Kabisch M, Kandler K, Lingvay I, Quiroga M, Rosenstock J, Garvey WT; STEP UP trial group. Once-weekly semaglutide 7.2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):949-963. doi: 10.1016/S2213-8587(25)00226-8. Epub 2025 Sep 14.
PubMed 40961952
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
- ClinicalTrials.gov ID
- NCT05646706
- Acronym / sponsor ID
- STEP UP / NN9536-4999
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,407 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 7.2 mg | Experimental | Drug: SemaglutideParticipants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72. |
| Semaglutide 2.4 mg | Experimental | Drug: SemaglutideParticipants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Key exclusion criteria (5 listed)
- HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
- Treatment with glucose-lowering agent(s) within 90 days before screening.
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideParticipants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Semaglutide 7.2 mg |
| SemaglutideParticipants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Semaglutide 2.4 mg |
| PlaceboParticipants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. | Drug | Placebo |
Primary outcome
Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
Time frame: At week 72
Number of participants who achieve body weight reduction >=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=5% and "no" defines participants who did not achieve body weight reduction >=5%.
44 secondary outcomes
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (%)
Time frame: Baseline (week 0), End of treatment (week 72)
Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)
Time frame: At week 72
Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline
Time frame: Baseline (week 0), End of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)
Time frame: Baseline (week 0), end of treatment (week 72)
Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)
Time frame: From baseline (week 0) to end of study (week 81)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42764399Hjelmesaeth J, Bhat S, Garvey WT, Kolnes KJ, Linge J, Lingvay I, Rasmussen NK, Rosenstock J, Wharton S. Effect of Semaglutide on Thigh Skeletal Muscle Volume, Fat Infiltration and Physical Function in People With Obesity: Secondary Analysis of STEP UP. Diabetes Obes Metab. 2026 Sep 20. doi: 10.1111/dom.71323. Online ahead of print.
- Derived from this study: PubMed 40961952Wharton S, Freitas P, Hjelmesaeth J, Kabisch M, Kandler K, Lingvay I, Quiroga M, Rosenstock J, Garvey WT; STEP UP trial group. Once-weekly semaglutide 7.2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial. Lancet Diabetes Endocrinol. 2025 Nov;13(11):949-963. doi: 10.1016/S2213-8587(25)00226-8. Epub 2025 Sep 14.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
107 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Obesity, run by Novo Nordisk A/S at 107 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States, Bulgaria, Germany, South Africa, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight (time frame: Baseline (week 0), End of treatment (week 72)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646706, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.