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NCT Number: NCT06299098

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion (FDI) Clinical Research, San Juan, Puerto Rico

Loading trial locations.

About this study

Part A Healthy Volunteers

Part B and Part C (starts after treatment for Part A has completed) Participants with Obesity

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

Part A

  • Male or female participants age ≥18 to ≤55 years of age at the time of screening
  • BMI ≥18 and ≤32 kg/m2, at the screening visit

Part B and Part C

  • Male or female participants ≥18 to ≤80 years of age at the time of screening
  • BMI ≥30 kg/m2, at the screening visit
  • History of 1 or more self-reported unsuccessful dietary attempts to lose weight

Key Exclusion Criteria

  • History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted
  • Previous bariatric surgery or planned bariatric surgery
  • History of hypertrophic cardiomyopathy
  • Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy
  • 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)
  • History of poorly controlled hypertension, as defined in the protocol
  • 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
  • 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
  • Has a history of any neuromuscular disorder (eg, multiple sclerosis, myasthenia gravis, myopathy, peripheral neuropathy, etc)

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Treatment and study plan

Trevogrumab-Part A

Drug

Administered IV or SC in Part A

Other names: REGN1033, GDF8

Trevogrumab-Part B and Part C

Drug

Administered SC in Part B, Part C

Other names: REGN1033, GDF8

garetosmab

Drug

Administered IV in Part B

Other names: REGN2477, Activin A

semaglutide

Drug

Administered SC in Part B and Part C

Other names: Wegovy®

Matching Placebo-Part A

Drug

Administered IV or SC in Part A

Matching Placebo-Trevogrumab

Drug

Administered SC in Part B and Part C

Matching Placebo-Garetosmab

Drug

Administered IV in Part B

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Baseline to week 7

    Part A

  2. Severity of TEAEs

    Time frame: Baseline to week 7

    Part A

  3. Percent change in total fat mass

    Time frame: Baseline to week 26

    Part B

  4. Percent change in total lean mass

    Time frame: Baseline to week 26

    Part B

  5. Percent change in body weight

    Time frame: Baseline to week 26

    Part B

  6. Percent change in total fat mass

    Time frame: Baseline to week 52

    Part C

  7. Percent change in total lean mass

    Time frame: Baseline to week 52

    Part C

  8. Percent change in body weight

    Time frame: Baseline to week 52

    Part C

Secondary outcomes

  1. Concentrations of trevogrumab in serum over time

    Time frame: Up to 75 weeks

    Part A, Part B, and Part C

  2. Percent change in total fat mass

    Time frame: Baseline to week 52

    Part B

  3. Percent change in total lean mass

    Time frame: Baseline to week 52

    Part B

  4. Percent change in body weight

    Time frame: Baseline to week 52

    Part B

  5. Change in waist circumference (cm)

    Time frame: Baseline to week 26

    Part B and Part C

  6. Change in waist circumference (cm)

    Time frame: Baseline to week 52

    Part C

  7. Percent change in fasting serum triglycerides

    Time frame: Baseline to week 26

    Part B

  8. Percent change in total cholesterol

    Time frame: Baseline to week 26

    Part B

  9. Percent change in Apolipoprotein B (Apo B)

    Time frame: Baseline to week 26

    Part B

  10. Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline to week 26

    Part B

  11. Concentrations of garetosmab in serum over time

    Time frame: Up to 75 weeks

    Part B

  12. Incidence of anti-drug antibodies (ADA) to trevogrumab after repeated doses over time

    Time frame: Up to 75 weeks

    Part B and Part C

  13. Magnitude of ADAs to trevogrumab over time

    Time frame: Up to 75 weeks

    Part B and Part C

  14. Incidence of ADAs to garetosmab after repeated doses over time

    Time frame: Up to 75 weeks

    Part B

  15. Magnitude of ADAs to garetosmab over time

    Time frame: Up to 75 weeks

    Part B

  16. Incidence of TEAEs

    Time frame: Up to 75 weeks

    Part B and Part C

  17. Severity of TEAEs

    Time frame: Up to 75 weeks

    Part B and Part C

  18. Percent change in total fat mass

    Time frame: Baseline to week 26

    Part C

  19. Percent change in total lean mass

    Time frame: Baseline to week 26

    Part C

  20. Percent change in body weight

    Time frame: Baseline to week 26

    Part C

  21. Concentration of total Growth Differentiation Factor (GDF) 8 in serum over time

    Time frame: Up to 75 weeks

    Part C

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: COURAGE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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