A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

NCTNCT07564414Other idNN9838-7910Other idU1111-1323-0372Other id2025-522488-14Other id2025

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Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 2,500 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 19 countries
United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, South Africa, Spain
Start: 21 May 2026
Primary completion: 23 Feb 2028 (estimated)
Completion: 19 Apr 2028 (estimated)
First posted: 4 May 2026
Last update posted: 30 Sept 2026
Conditions: Obesity · Type 2 Diabetes

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 3
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
NCT07564414
21 May 2026 to est. 19 Apr 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Interventions

CagrisemaDrug
SemaglutideDrug

Arms3

Experimental
Cagrisema - dose level 1
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
Active comparator
Cagrisema - dose level 2
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
Active comparator
Semaglutide
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as percentage (%).

Secondary outcomes(20)

Relative change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as %.
Change in Body Mass Index (BMI)
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as kilograms per square metre (kg/m\^2).
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as count of participants.
Number of participants who achieve ≥25% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as count of participants.
Number of participants who achieve greater ≥ 20% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as count of participants.
Change in waist circumference
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured in centimetre (cm).
Mean change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured in kilograms (kg).
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as count of participants.
Number of participants who achieve BMI <27 kg/m^2
Time frame · end of treatment (week 72)
Registry description
Measured as count of participants.
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Time frame · At end of treatment (week 72)
Registry description
Measured as count of participants.
Number of participants who achieve a waist-to-height ratio < 0.53
Time frame · At end of treatment (week 72)
Registry description
Measured as count of participants.
Ratio to baseline : Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline : Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline: Free fatty acids
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Ratio to baseline : Non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 72)
Registry description
Measured in terms of ratio.
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
Measured as score on a scale. The 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, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Time frame · From randomisation (week 0) to end of treatment (week 72)
Registry description
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. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria : * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * BMI≥ 35.0 kg/m\^2. * Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised. Exclusion Criteria: * A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records. * Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

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