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
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Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
1,005
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2024-03-13
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Number of sites
60
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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)
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Acronym
COURAGE
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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
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-10-30
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First posted
2024-03-07
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Registry last updated
2026-07-21
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Primary completion date
2026-05-06
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Start date
2024-03-13
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Actual participants
1,005
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Participants
1,005
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
60
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06299098
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ClinicalTrials.gov ID
NCT06299098
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
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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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (3)