> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-to-look-at-how-two-different-doses-of-76a42b8a-318d-4ae8-8ea2-46e58c1e3a81 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Participants 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Start date 2026-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) Number of sites 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Dates **Completion date** 2028-04-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **First posted** 2026-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Primary completion date** 2028-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Start date** 2026-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Size and sites **Participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Planned participants** 2,500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Number of sites** 303 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Identifiers **Registry ID** NCT07564414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **ClinicalTrials.gov ID** NCT07564414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Study design **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 Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Outcomes ### Primary outcomes 1. Relative change in body weight Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured as percentage (%). ### Secondary outcomes 1. Relative change in body weight Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured as %. 2. 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). 3. 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. 4. Number of participants who achieve ≥25% weight reduction Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured as count of participants. 5. 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. 6. Change in waist circumference Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured in centimetre (cm). 7. Mean change in body weight Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured in kilograms (kg). 8. 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. 9. Number of participants who achieve BMI <27 kg/m^2 Timeframe: end of treatment (week 72) Measured as count of participants. 10. 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. 11. Number of participants who achieve a waist-to-height ratio < 0.53 Timeframe: At end of treatment (week 72) Measured as count of participants. 12. Ratio to baseline : Total cholesterol Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 13. Ratio to baseline : High density lipoprotein (HDL) cholesterol Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 14. Ratio to baseline : Low density lipoprotein (LDL) cholesterol Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 15. 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. 16. Ratio to baseline : Triglycerides Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 17. Ratio to baseline: Free fatty acids Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 18. Ratio to baseline : Non-HDL cholesterol Timeframe: From baseline (week 0) to end of treatment (week 72) Measured in terms of ratio. 19. 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. 20. 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. 21. Change in glycated haemoglobin (HbA1c) Timeframe: From randomisation (week 0) to end of treatment (week 72) Measured in %-points. 22. Number of participants who achieve HbA1c <6.5% Timeframe: At end of treatment (week 72) Measured as count of participants. 23. Number of participants who achieve normal HbA1c <5.7% Timeframe: At end of treatment (week 72) Measured as count of participants. 24. Number of treatment-emergent adverse events (TEAEs) Timeframe: From randomisation (week 0) to end of study (week 80) Measured in number of events. 25. Number of treatment-emergent serious adverse events (TESAEs) Timeframe: From randomisation (week 0) to end of study (week 80) Measured in number of events. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## References ### Other registry identifiers (3) - 2025 - U1111-1323-0372 - 2025-522488-14 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07564414) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (2) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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