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
- Summary
- 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
- Short title
- 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
- Official title
- A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-04-19
- First posted
- 2026-05-04
- Registry last updated
- 2026-07-30
- Primary completion date
- 2028-02-23
- Start date
- 2026-05-21
- Participants
- 2,500
- Participant count basis
- Estimated
- Planned participants
- 2,500
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07564414
- ClinicalTrials.gov ID
- NCT07564414
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masking description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Relative change in body weight
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).
Relative change in body weight
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as %.
Change in Body Mass Index (BMI)
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as kilograms per square metre (kg/m\^2).
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve ≥25% weight reduction
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve greater ≥ 20% weight reduction
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Change in waist circumference
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured in centimetre (cm).
Mean change in body weight
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured in kilograms (kg).
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve BMI <27 kg/m^2
Timeframe: end of treatment (week 72)
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
Timeframe: At end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve a waist-to-height ratio < 0.53
Timeframe: At end of treatment (week 72)
Measured as count of participants.
Ratio to baseline : Total cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline : Triglycerides
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline: Free fatty acids
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Ratio to baseline : Non-HDL cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Timeframe: From randomisation (week 0) to end of treatment (week 72)
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
Timeframe: From randomisation (week 0) to end of treatment (week 72)
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.
Change in glycated haemoglobin (HbA1c)
Timeframe: From randomisation (week 0) to end of treatment (week 72)
Measured in %-points.
Number of participants who achieve HbA1c <6.5%
Timeframe: At end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve normal HbA1c <5.7%
Timeframe: At end of treatment (week 72)
Measured as count of participants.
Number of treatment-emergent adverse events (TEAEs)
Timeframe: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
Number of treatment-emergent serious adverse events (TESAEs)
Timeframe: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- Uni of Alabama at BirminghamBirmingham, United StatesRecruiting
- Cahaba ResearchPelham, United StatesRecruiting
- Elligo Health Research IncGilbert, United StatesRecruiting
- Velocity Clinical Research-PhoenixPhoenix, United StatesRecruiting
- Arkansas Clinical ResearchLittle Rock, United StatesRecruiting
- Woodland Int. Research GroupLittle Rock, United StatesRecruiting
- Headlands Research California, LLCEscondido, United StatesRecruiting
- Neighborhood HealthcareEscondido, United StatesRecruiting
- Diabetes & Endocrine Specialists - La MesaLa Mesa, United StatesRecruiting
- Clinical Trials Research_SacramentoLincoln, United StatesRecruiting
- Loma Linda University Faculty Medical ClinicsLoma Linda, United StatesRecruiting
- Pacific Clinical StudiesLos Alamitos, United StatesRecruiting
- Valley Clinical TrialsNorthridge, United StatesRecruiting
- Desert Oasis HealthcarePalm Springs, United StatesRecruiting
- Linda Vista Health Care CtrSan Diego, United StatesRecruiting
- Velocity Clin Res - Van NuysVan Nuys, United StatesRecruiting
- Flourish Research - CAWalnut Creek, United StatesRecruiting
- University of Colorado HospitalAurora, United StatesRecruiting
- TBMR & AlcanzaClearwater, United StatesRecruiting
- Northeast Research InstituteFleming Island, United StatesRecruiting
- Northeast Research InstituteJacksonville, United StatesRecruiting
- Westside Center For Clinical ResearchJacksonville, United StatesRecruiting
- Bioclinical Research AllianceMiami, United StatesRecruiting
- New Horizon Research CenterMiami, United StatesRecruiting
- South Broward Research LLCMiramar, United StatesRecruiting
And 278 more, listed on the interactive page.
- 2025
- U1111-1323-0372
- 2025-522488-14
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Type 2 diabetes mellitus