ObesityPhase 3RENEW 1NCT07220642
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
A Phase 3 study testing Cagrilintide in people with Obesity and Overweight, run by Novo Nordisk A/S at 40 sites in 10 countries.
Trial summary
This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Cagrilintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 40 sitesin 10 countries
- Study dates
- 5 Nov 2025to 29 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Female or male (sex at birth)
- Age 18 years or above at the time of signing the informed consent
- History of at least one self-reported unsuccessful dietary effort to lose body weight (a*)
- Body mass index (BMI) greater than or equal to >= 30.0 kilogram per square meter (kg/m^2), or BMI greater than or equal to >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a*)
Who cannot join
- History of type 1 or type 2 diabetes (a*)
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a*)
- Previous dosing of marketed or non-marketed amylin-based compounds (a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
Trial locations and contacts
40 sites in 10 countries.
40 sites in 10 countries
United States9 sites
Univ of Colorado at Denver
Aurora, Colorado, 80045
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
Walgreens - Store 11760
Oak Park, Illinois, 60302
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Selma Medical Associates
Winchester, Virginia, 22601-3834
Canada8 sites
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 1V7
Hamilton Medical Research Group
Hamilton, Ontario, L8L 5G4
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, L8L 5G8
Milestone Research
London, Ontario, N5W 6A2
Centricity Research Mirabel
Mirabel, Quebec, J7J 2K8
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7
Centricity Research Oshawa
Oshawa, Ontario, L1J 2K9
Centricity Research Toronto
Toronto, Ontario, M4G 3E8
Italy4 sites
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
Bologna, 40138
IRCCS Ospedale San Raffaele Milano
Milan, 20132
AOUP Giaccone Palermo
Palermo, Sicily, 90127
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Rome, RM, 00168
Poland4 sites
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, 15-351
Care Clinic Sp. z o. o.
Katowice, 40-568
Terpa Sp. z o.o. Sp. k.
Lublin, 20-333
NBR Polska Tomasz Klodawski
Warsaw, 00-710
Germany3 sites
InnoDiab Forschung GmbH
Essen, 45136
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Norway3 sites
Haukeland Universitetssykehus
Bergen, 5021
Drammen sykehus - Vestre Viken HF
Drammen, 3004
St. Olavs Hospital HF_Endokrinologisk avdeling
Trondheim, NO-7030
United Kingdom3 sites
Oak Tree Surgery
Liskeard, Cornwall, PL14 3XA
North Coast Medical Ltd
Newquay, Cornwall, TR7 1RU
Brunel Medical Practice
Torquay, Devon, TQ1 4QX
Argentina2 sites
CIPREC Pueyrredon
Buenos Aires, C1119ACN
CEDIC Centro de Investigación Clínica
CABA, C1060ABA
Australia2 sites
Sydney Cardiometabolic Centre
Liverpool, New South Wales, 2170
Hunter Diabetes Centre
Merewether, New South Wales, 2291
France2 sites
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, 44800
Centre de Recherche Clinique Portes Du Sud
Vénissieux, 69200
About this study
Official title: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity
This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.
- Conditions
- Obesity, Overweight
- Being tested
- Cagrilintide, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
PlaceboDrug
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide | Experimental | Participants will receive cagrilintide subcutaneously once weekly for 64 weeks. Receives: Drug: Cagrilintide |
| Placebo | Placebo comparator | Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage (%).
Measured: From baseline (week 0) to end of treatment (week 64)
Secondary outcomes (27)
Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 15 % body weight reduction (yes/no)
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in waist circumference
Measured as centimeters (cm).
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in triglycerides
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in Systolic Blood Pressure (SBP)
Measured as millimeter of mercury (mmHg).
Measured: From baseline (week 0) to end of treatment (week 64)
Change in body weight
Measured as kilograms (kg).
Measured: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 5 % body weight reduction (yes/no)
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® mental component summary score
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in IWQOL-Lite-CT total score
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Measured: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no)
Measured as count of participants. IWQOL-Lite-CT measures weight related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in Diastolic Blood Pressure (DBP)
Measured as mmHg.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of total cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of non-HDL cholesterol
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of free fatty acids
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in glycated haemoglobin (HbA1c) percentage-points (%-points)
Measured as %-points.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in HbA1c millimoles per mole (mmol/mol)
Measured as mmol/mol.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L)
Measured as mmol/L.
Measured: From baseline (week 0) to end of treatment (week 64)
Change in FPG milligrams per deciliter (mg/dL)
Measured as mg/dL.
Measured: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in fasting serum insulin
Measured as ratio.
Measured: From baseline (week 0) to end of treatment (week 64)
Number of treatment emergent adverse events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (week 71)
Number of treatment emergent serious adverse events (TESAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of study (week 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start5 Nov 2025
- Primary completion11 May 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 participants (estimated)
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
- NCT07220642
- Sponsor's protocol ID
- NN9833-8242
- Other IDs
- U1111-1314-8906, 2024-519530-24
- Acronym
- RENEW 1
- Status last verified
- Aug 2026
- First submitted
- 23 Oct 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07220642
- Acronym / sponsor ID
- RENEW 1 / NN9833-8242
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
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 cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cagrilintide | Experimental | Drug: CagrilintideParticipants will receive cagrilintide subcutaneously once weekly for 64 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Female or male (sex at birth)
- Age 18 years or above at the time of signing the informed consent
- History of at least one self-reported unsuccessful dietary effort to lose body weight (a*)
- Body mass index (BMI) greater than or equal to >= 30.0 kilogram per square meter (kg/m^2), or BMI greater than or equal to >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a*)
Key exclusion criteria (3 listed)
- History of type 1 or type 2 diabetes (a*)
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a*)
- Previous dosing of marketed or non-marketed amylin-based compounds (a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
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 |
|---|---|---|
| CagrilintideCagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. | Drug | Cagrilintide |
| PlaceboPlacebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 64)
Measured as percentage (%).
27 secondary outcomes
Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 15 % body weight reduction (yes/no)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in waist circumference
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in triglycerides
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in body weight
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of >= 5 % body weight reduction (yes/no)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in SF-36v2® mental component summary score
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in IWQOL-Lite-CT total score
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in Diastolic Blood Pressure (DBP)
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of total cholesterol
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of non-HDL cholesterol
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline of free fatty acids
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in glycated haemoglobin (HbA1c) percentage-points (%-points)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in HbA1c millimoles per mole (mmol/mol)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L)
Time frame: From baseline (week 0) to end of treatment (week 64)
Change in FPG milligrams per deciliter (mg/dL)
Time frame: From baseline (week 0) to end of treatment (week 64)
Ratio to baseline in fasting serum insulin
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (week 0) to end of study (week 71)
Number of treatment emergent serious adverse events (TESAEs)
Time frame: From baseline (week 0) to end of study (week 71)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.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
40 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cagrilintide in people with Obesity and Overweight, run by Novo Nordisk A/S at 40 sites in 10 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada, Italy, Poland, Germany and 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 64)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.