AzTrials
AzTrials

Obesity or OverweightPhase 3REDEFINE 6NCT05996848

A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity or Overweight, run by Novo Nordisk A/S at 37 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. 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 or Overweight
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
300 participants
Where
37 sitesChina
Study dates
15 Aug 2023to 22 Feb 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
  • 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 kilograms 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, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
  • Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
Show all 9Show fewer
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening
  • Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening

Who cannot join

  • For participants without T2D at screening:
  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus
  • For participants with T2D at screening:
  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2), as measured by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853

  • The first hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun, Jilin, 130061

  • The First People's Hospital of Changde City-Endocrinology

    Changde, Hunan, 415003

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • Fujian Medical University Union Hospital-Endocrinology

    Fuzhou, Fujian, 350001

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong, 516001

  • Jinan Central Hospital

    Ji'nan, Shandong, 250013

  • Jinan Central Hospital

    Jin'an, Shandong, 250013

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Huashan Hospital Fudan University

    Jingan/Shanghai, 200040

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan, 475000

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000

  • The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Henan university of Science

    Luoyang, Henan, 471003

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine

    Shanghai, Shanghai Municipality, 200336

  • Tongren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200336

  • Central Hospital of Minhang District, Shanghai-Endocrinology

    Shanghai, Shanghai Municipality, 201199

  • Central Hospital of Minhang District-Endocrinology

    Shanghai, Shanghai Municipality, 201199

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 201200

  • The Second Hospital of Hebei Medical University-Endocrinology

    Shijiazhuang, Hebei, 050000

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Suzhou Municipal Hospital-Endocrinology

    Suzhou, Jiangsu, 215002

  • The First Affiliated Hospital of Soochow University-Endocrinology

    Suzhou, Jiangsu, 215006

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin Municipality, 300052

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

  • The Second Affiliated Hospital of Zhengzhou University-Endocrinology

    Zhengzhou, Henan, 450003

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450003

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

About this study

Official title: Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants With Overweight or Obesity

This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.

Being tested
Cagrilintide, Semaglutide, Placebo Semaglutide, Placebo Cagrilintide
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

    Participants will receive 2.4 mg cagrilintide subcutaneously.

  • SemaglutideDrug

    Participants will receive 2.4 mg semaglutide subcutaneously.

  • Placebo SemaglutideDrug

    Participants will receive placebo matched to semaglutide subcutaneously.

  • Placebo CagrilintideDrug

    Participants will receive placebo matched to cagrilintide subcutaneously.

Study groups in NCT05996848
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
SemaglutideActive comparatorParticipants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
Receives: Drug: Semaglutide; Drug: Placebo Semaglutide
PlaceboPlacebo comparatorParticipants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
Receives: Drug: Placebo Semaglutide; Drug: Placebo Cagrilintide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  2. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%

    Measured as count of participants

    Measured: From baseline (week 0) to end of treatment (week 44)

Secondary outcomes (26)

  1. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%

    Measured as count of participants

    Measured: From baseline (week 0) to end of treatment (week 44)

  2. CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  3. CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference

    Measured in centimeter (cm)

    Measured: From baseline (week 0) to end of treatment (week 44)

  4. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%

    Measured as count of participants

    Measured: From baseline (week 0) to end of treatment (week 44)

  5. CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%

    Measured as count of participants

    Measured: From baseline (week 0) to end of treatment (week 44)

  6. CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference

    Measured in centimeter (cm)

    Measured: From baseline (week 0) to end of treatment (week 44)

  7. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)

    Measured in percentage points

    Measured: From baseline (week 0) to end of treatment (week 44)

  8. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)

    Measured as millimole per liter (mmol/L)

    Measured: From baseline (week 0) to end of treatment (week 44)

  9. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  10. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)

    Measured in millimeter of mercury (mmHg)

    Measured: From baseline (week 0) to end of treatment (week 44)

  11. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)

    Measured in millimeter of mercury (mmHg)

    Measured: From baseline (week 0) to end of treatment (week 44)

  12. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  13. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  14. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  15. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  16. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  17. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 44)

  18. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score

    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic clinical outcome assessment (COA) instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical functioning domain'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 correspond to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

    Measured: From baseline (week 0) to end of treatment (week 44)

  19. CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score

    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'physical component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

    Measured: From baseline (week 0) to end of treatment (week 44)

  20. CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score

    Measured as score points. The SF-36v2.0 is a 36-item commonly used generic COA instrument measuring health-related quality of life and general health status across disease areas. SF-36v2 questionnaire measures 8 domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint assess the 'mental component summary'. The 0-100 scale scores from the SF-36 will be converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively. A positive change score indicates an improvement since baseline.

    Measured: From baseline (week 0) to end of treatment (week 44)

  21. CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'physical function score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.

    Measured: From baseline (week 0) to end of treatment (week 44)

  22. CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. This endpoint assess the 'total score'. The scores range between 0-100 where higher scores indicate a better quality of life. A positive change score indicates an improvement since baseline.

    Measured: From baseline (week 0) to end of treatment (week 44)

  23. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 51)

  24. CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study (week 51)

  25. Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)

    Measured as count of episodes

    Measured: From baseline (week 0) to end of study (week 51)

  26. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)

    Measured as count of episodes

    Measured: From baseline (week 0) to end of study (week 51)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start15 Aug 2023
  3. Primary completion6 Jan 2025
  4. Study completion22 Feb 2025

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996848
Sponsor's protocol ID
NN9838-4827
Other IDs
U1111-1267-4364
Acronym
REDEFINE 6
Status last verified
Jan 2026
First submitted
10 Aug 2023
Last updated
9 Jan 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity or Overweight, run by Novo Nordisk A/S at 37 sites in China.

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 9 inclusion and 7 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. 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?

CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 44)). 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 NCT05996848.

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 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in