Type 2 DiabetesPhase 3REIMAGINE 3NCT06323161
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 61 sites in 6 countries.
Trial summary
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Cagrilintide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 61 sitesin 6 countries
- Study dates
- 26 Mar 2024to 23 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
- On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
- Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Trial locations and contacts
61 sites in 6 countries.
61 sites in 6 countries
United States18 sites
University of North Carolina
Chapel Hill, North Carolina, 27614
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
Elite Research Center
Flint, Michigan, 48532
Valley Research
Fresno, California, 93720
Synergy Groups Medical
Houston, Texas, 77061
PlanIt Research, PLLC
Houston, Texas, 77079
Holston Medical Group
Kingsport, Tennessee, 37660
Palm Research Center Inc.
Las Vegas, Nevada, 89128
Manassas Clinical Research Center
Manassas, Virginia, 20110
Solaris Clinical Research
Meridian, Idaho, 83646
Bioclinical Research Alliance
Miami, Florida, 33155
Clinical Research Associates
Nashville, Tennessee, 37203
TPMG Clinical Research
Newport News, Virginia, 23606
Alliance for Multispec Res
Newton, Kansas, 67114
Valley Clinical Trials, Inc.
Northridge, California, 91325
Endo and Metab Consultants
Rockville, Maryland, 20852
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266
Japan16 sites
Kumanomae Nishimura Naika Clinic_Internal Medicine
Arakawa-ku, Tokyo, 116-0012
Akaicho Clinic
Chiba-shi, Chiba, 260-0804
Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, 819-0006
Kunisaki Makoto Clinic
Fukuoka-shi, Fukuoka, 819-0168
Sasaki Internal Medicine
Hokkaido, 062-0007
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
H.E.C Science Clinic_Internal Medicine, Diabetes
Kanagawa, 235-0045
H.E.C Science Clinic
Kanagawa, 235-0045
Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto, 606-8507
Minami Akatsuka Clinic_internal medicine
Mito-shi, Ibaraki, 311-4153
Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031
Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, 125-0054
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004
China9 sites
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853
Jinan Central Hospital
Ji'nan, Shandong, 250013
Jinan Central Hospital
Jinan, Shandong, 250013
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, 475000
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, 210011
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 201200
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001
South Africa8 sites
Oraderumaz (Pty) Ltd
Bloemfontein, Free State, 9301
Ashmed Medi-Centre
Cape Town, Western Cape, 7760
Dr Vawda's site
Durban, KwaZulu-Natal, 4091
Hemant Makan
Johannesburg, Gauteng, 1827
Lenasia Clinical Trial Centre
Lenasia, Gauteng, 1827
Prinshof Medical Campus
Pretoria, Gauteng, 0002
Clinical Trial Systems (CTC)
Pretoria, Gauteng, 0186
Dr Noeth's Practice
Pretoria, 0002
Serbia5 sites
Healthcare centre Zvezdara
Belgrade, RS, 11050
Healthcare centre Kragujevac
Kragujevac, RS, 34000
University Clinical Centre Nis
Niš, RS, 18 000
Healthcare centre Nis
Niš, RS, 18000
Policlinic for diabetes
Zaječar, 19000
Slovakia5 sites
MOMED, s.r.o
Kráľovský Chlmec, 077 01
DIA - KONTROL s.r.o.
Levice, 93401
SIN AZUCAR s.r.o.
Malacky, 901 01
ENRIN, s.r.o.
Rimavská Sobota, 979 01
LUDIA, s. r. o.
Spišská Nová Ves, 05201
About this study
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin
This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
- Conditions
- Type 2 Diabetes
- Being tested
- Cagrilintide, Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Participants will receive once-weekly cagrilintide subcutaneously.
SemaglutideDrug
Participants will receive once-weekly semaglutide subcutaneously.
PlaceboDrug
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CagriSema Dose 1 | Active comparator | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| CagriSema Dose 2 | Active comparator | Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. Receives: Drug: Cagrilintide; Drug: Semaglutide |
| Placebo Dose 1 | Placebo comparator | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks. Receives: Drug: Placebo |
| Placebo Dose 2 | Placebo comparator | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Haemoglobin (HbA1c)
Measured in percentage (%)- points.
Measured: From baseline (week 0) to end of treatment (week 40)
Secondary outcomes (31)
Relative Change in Body Weight
Measured in percentage (%).
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥15% Body Weight Reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Measured as count of participants.
Measured: At end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)
Measured as count of participants.
Measured: At end of treatment (week 40)
Change in Fasting Plasma Glucose (FPG)
Measured as millimole per liter (mmol/L).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Insulin Dose
Measured in units (u).
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units
Measured as count of participants.
Measured: At end of treatment (week 40)
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Measured in mmol/L.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥5% Body Weight Reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥20% Body Weight Reduction
Measured as count of participants.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Waist Circumference
Measured in centimeter (cm).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Systolic Blood Pressure (SBP)
Measured in millimeter of mercury (mmHg).
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Diastolic Blood Pressure (DBP)
Measured in mmHg.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP)
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Triglycerides
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: HDL Cholesterol
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Total Cholesterol
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Free Fatty Acids
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score
Measured as score points. 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 vitality score range is from 25.6 to 69.1.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Physical Component Summary Score
Measured as score points. SF-36v2 Acute measures 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 score range for physical component summary is 6.1 to 79.7.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Mental Component Summary Core
Measured as score points. SF-36v2 Acute measures 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 score range for mental component summary score is -3.8 to 78.7.
Measured: From baseline (week 0) to end of treatment (week 40)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Measured as score points. DTSQs measures treatment satisfaction and diabetes-specific quality of life. The measure consists of 8 items yielding 1 global score and 2 single item scores. Higher scores on the global score indicate greater satisfaction with treatment. Lower scores on the single-item scores indicate BG levels closer to the ideal, while higher scores indicate problems. Single-item scores (score range): Perceived frequency of hyperglycaemia (0-6), Perceived frequency of hypoglycaemia (0-6). Global score (score range): Total Treatment Satisfaction (0-36).
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Leptin
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Soluble Leptin Receptor
Measured in ratio.
Measured: From baseline (week 0) to end of treatment (week 40)
Number of Treatment Emergent Adverse Events (TEAEs)
Measured as count of events.
Measured: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter)
Measured as count of episodes.
Measured: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 3)
Measured as count of episodes. Hypoglycaemic episodes (level 3) is hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold.
Measured: From baseline (week 0) to end of treatment +7 weeks (week 47)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start26 Mar 2024
- Primary completion9 Sep 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- 274 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
- NCT06323161
- Sponsor's protocol ID
- NN9388-7637
- Other IDs
- U1111-1283-0754, 2022-502679-43
- Acronym
- REIMAGINE 3
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 9 Sep 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
Publications
Rosenstock J, Billings LK, Gajria R, Giorgino F, Johansen NB, Klein KR, Thamattoor UK, Buse JB, Jain AB. Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet. 2026 Jul 4;408(10549):38-51. doi: 10.1016/S0140-6736(26)01022-6. Epub 2026 Jun 7.
PubMed 42251856
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes as Add on to Once-daily Basal Insulin With or Without Metformin
- ClinicalTrials.gov ID
- NCT06323161
- Acronym / sponsor ID
- REIMAGINE 3 / NN9388-7637
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 9 Sep 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 21 Mar 2024 (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 CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CagriSema Dose 1 | Active comparator | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks. |
| CagriSema Dose 2 | Active comparator | Drug: Cagrilintide, Drug: SemaglutideParticipants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 24 weeks. |
| Placebo Dose 1 | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 40 weeks. |
| Placebo Dose 2 | Placebo comparator | Drug: PlaceboParticipants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 40 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
- On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
Key exclusion criteria (6 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
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 |
|---|---|---|
| CagrilintideParticipants will receive once-weekly cagrilintide subcutaneously. | Drug | CagriSema Dose 1, CagriSema Dose 2 |
| SemaglutideParticipants will receive once-weekly semaglutide subcutaneously. | Drug | CagriSema Dose 1, CagriSema Dose 2 |
| PlaceboParticipants will receive placebo matched to cagrilintide and semaglutide subcutaneously. | Drug | Placebo Dose 1, Placebo Dose 2 |
Primary outcome
Change in Glycated Haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of treatment (week 40)
Measured in percentage (%)- points.
31 secondary outcomes
Relative Change in Body Weight
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥15% Body Weight Reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Time frame: At end of treatment (week 40)
Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)
Time frame: At end of treatment (week 40)
Change in Fasting Plasma Glucose (FPG)
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Insulin Dose
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units
Time frame: At end of treatment (week 40)
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥5% Body Weight Reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Participants Who Achieve ≥20% Body Weight Reduction
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Waist Circumference
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Systolic Blood Pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Diastolic Blood Pressure (DBP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP)
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Triglycerides
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: HDL Cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Total Cholesterol
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Lipids: Free Fatty Acids
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Physical Component Summary Score
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in SF-36v2: Mental Component Summary Core
Time frame: From baseline (week 0) to end of treatment (week 40)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Leptin
Time frame: From baseline (week 0) to end of treatment (week 40)
Ratio to Baseline in Soluble Leptin Receptor
Time frame: From baseline (week 0) to end of treatment (week 40)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter)
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Number of Clinically Significant Hypoglycaemic Episodes (level 3)
Time frame: From baseline (week 0) to end of treatment +7 weeks (week 47)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 42251856Rosenstock J, Billings LK, Gajria R, Giorgino F, Johansen NB, Klein KR, Thamattoor UK, Buse JB, Jain AB. Cagrilintide-semaglutide (CagriSema) as an add-on to basal insulin in adults with type 2 diabetes (REIMAGINE 3): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet. 2026 Jul 4;408(10549):38-51. doi: 10.1016/S0140-6736(26)01022-6. Epub 2026 Jun 7.
- 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
61 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 61 sites in 6 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 6 inclusion and 6 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Japan, China, South Africa, Serbia and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Glycated Haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 40)). 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 NCT06323161, which also lists 1 linked publication.
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 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.