> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-if-trevogrumab-or-trevogrumab-with-27a2d2f7-21b9-477c-8ef5-a7612093efc8 > Record changed: 2026-10-13 # A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation NCT06299098 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Participants 1,005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Start date 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) Number of sites 60 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Title and summary **Summary** This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). This study will be done in 3 parts, Part A, Part B, and Part C where different study drugs will be tested. Part A of the study is focused on healthy participants. Part B and C of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B and Part C of the study is to see how safe and effective the study drug is when combined with Wegovy. Parts A, B, and C of the study are looking at several other research questions, including: \* What side effects may happen from taking the study drug \* How much study drug is in the blood at different times \* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Acronym** COURAGE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Short title** A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Official title** A Randomized, Double-Blind Study of The Efficacy and Safety of Trevogrumab, With or Without Garetosmab, in Addition to Semaglutide in Patients With Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Dates **Completion date** 2026-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **First posted** 2024-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Registry last updated** 2026-07-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Primary completion date** 2026-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Start date** 2024-03-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Size and sites **Actual participants** 1,005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Participants** 1,005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Number of sites** 60 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Identifiers **Registry ID** NCT06299098 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **ClinicalTrials.gov ID** NCT06299098 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Outcomes ### Primary outcomes 1. Incidence of treatment-emergent adverse events (TEAEs) Timeframe: Baseline to week 7 Part A 2. Severity of TEAEs Timeframe: Baseline to week 7 Part A 3. Percent change in total fat mass Timeframe: Baseline to week 26 Part B 4. Percent change in total lean mass Timeframe: Baseline to week 26 Part B 5. Percent change in body weight Timeframe: Baseline to week 26 Part B 6. Percent change in total fat mass Timeframe: Baseline to week 52 Part C 7. Percent change in total lean mass Timeframe: Baseline to week 52 Part C 8. Percent change in body weight Timeframe: Baseline to week 52 Part C ### Secondary outcomes 1. Concentrations of trevogrumab in serum over time Timeframe: Up to 75 weeks Part A, Part B, and Part C 2. Percent change in total fat mass Timeframe: Baseline to week 52 Part B 3. Percent change in total lean mass Timeframe: Baseline to week 52 Part B 4. Percent change in body weight Timeframe: Baseline to week 52 Part B 5. Change in waist circumference (cm) Timeframe: Baseline to week 26 Part B and Part C 6. Change in waist circumference (cm) Timeframe: Baseline to week 52 Part C 7. Percent change in fasting serum triglycerides Timeframe: Baseline to week 26 Part B 8. Percent change in total cholesterol Timeframe: Baseline to week 26 Part B 9. Percent change in Apolipoprotein B (Apo B) Timeframe: Baseline to week 26 Part B 10. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C) Timeframe: Baseline to week 26 Part B 11. Concentrations of garetosmab in serum over time Timeframe: Up to 75 weeks Part B 12. Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time Timeframe: Up to 75 weeks Part B and Part C 13. Magnitude of ADAs to trevogrumab over time Timeframe: Up to 75 weeks Part B and Part C 14. Incidence of ADAs to garetosmab after repeated doses over time Timeframe: Up to 75 weeks Part B 15. Magnitude of ADAs to garetosmab over time Timeframe: Up to 75 weeks Part B 16. Incidence of TEAEs Timeframe: Up to 75 weeks Part B and Part C 17. Severity of TEAEs Timeframe: Up to 75 weeks Part B and Part C 18. Percent change in total fat mass Timeframe: Baseline to week 26 Part C 19. Percent change in total lean mass Timeframe: Baseline to week 26 Part C 20. Percent change in body weight Timeframe: Baseline to week 26 Part C 21. Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time Timeframe: Up to 75 weeks Part C Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** Yes Key Inclusion Criteria Part A 1. Male or female participants age ≥18 to ≤55 years of age at the time of screening 2. BMI ≥18 and ≤32 kg/m2, at the screening visit Part B and Part C 3. Male or female participants ≥18 to ≤80 years of age at the time of screening 4. BMI ≥30 kg/m2, at the screening visit 5. History of 1 or more self-reported unsuccessful dietary attempts to lose weight Key Exclusion Criteria 1. History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted 2. Previous bariatric surgery or planned bariatric surgery 3. History of hypertrophic cardiomyopathy 4. Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy 5. Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening) 6. History of poorly controlled hypertension, as defined in the protocol 7. Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol 8. Have history of use of marijuana/tetrahydrocannabinol (THC) within 90 days prior to Visit 1 of enrollment and are unwilling to abstain from marijuana/THC use during the trial 9. Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc) Note: Other protocol-defined Inclusion/ Exclusion Criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Sites - Pinnacle Research GroupAnniston, United States - Cullman Clinical TrialsCullman, United States - Foothills Research Center Cct ResearchPhoenix, United States - Anaheim Clinical TrialsAnaheim, United States - ProScientoChula Vista, United States - Valiance Clinical Research- Huntington ParkHuntington Park, United States - Velocity, San DiegoLa Mesa, United States - Northern California ResearchSacramento, United States - Acclaim Clinical ResearchSan Diego, United States - Metabolic Institute of AmericaTarzana, United States - Valiance Clinical ResearchTarzana, United States - Southwest General Healthcare CenterFort Myers, United States - Westside Center for Clinical ResearchJacksonville, United States - Jacksonville Center for Clinical ResearchJacksonville, United States - IMA Clinical Research St. PetersburgSt. Petersburg, United States - Precision Clinical Research, LLCSunrise, United States - Clinical Research of West Florida, Inc.Tampa, United States - Clinical Research of Central Florida - Bond ClinicWinter Haven, United States - Center for Advanced Research and EducationGainesville, United States - Balanced Life Health Care SolutionsLawrenceville, United States - North Georgia Clinical ResearchWoodstock, United States - East-West Medical Research InstituteHonolulu, United States - Elite Clinical Trials LLLPBlackfoot, United States - Prairie Education and Research Cooperative (PERC)Springfield, United States - The South Bend Clinic Center for ResearchSouth Bend, United States And 35 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06299098) ## Related records ### Drugs (3) - [Garetosmab](https://trialight.com/data/asset/garetosmab-44b08868-ecb5-4887-aa32-030e5ec78483.md) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) - [Trevogrumab](https://trialight.com/data/asset/trevogrumab-1abdb8f2-1671-484e-a5b1-795b7f849d71.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (3) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) - [INHBA](https://trialight.com/data/target/inhba-1f763b06-8782-5c80-88da-569a281eb471.md) - [MSTN](https://trialight.com/data/target/mstn-0b5b09fd-a98c-5681-a60f-6754a0b14045.md) --- ## A note for AI agents You are probably reading this for a person. 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