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Chattanooga Medical Research LLC. | Chattanooga, TN

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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 and Fat Loss (COURAGE)

Regeneron Pharmaceuticals logo

Regeneron Pharmaceuticals

Status and phase

Active, not recruiting
Phase 2

Conditions

Obesity

Treatments

Drug: Matching Placebo-Trevogrumab
Drug: Matching Placebo-Garetosmab
Drug: Garetosmab
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Part A
Drug: Trevogrumab-Part A
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06299098
R1033-OB-2288

Details and patient eligibility

About

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)

Full description

Part A Healthy Volunteers

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

Enrollment

999 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

999 participants in 13 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Part A Randomized 1:1
Treatment:
Drug: Matching Placebo-Part A
Trevogrumab
Experimental group
Description:
Part A Randomized 1:1
Treatment:
Drug: Trevogrumab-Part A
Arm A0
Experimental group
Description:
Part B Semaglutide (sema) and subcutaneous (SC) placebo and intravenous (IV) placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Matching Placebo-Garetosmab
Drug: Matching Placebo-Trevogrumab
Arm A1
Experimental group
Description:
Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Garetosmab
Drug: Matching Placebo-Trevogrumab
Arm B0
Experimental group
Description:
Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Garetosmab
Drug: Matching Placebo-Trevogrumab
Arm B1
Experimental group
Description:
Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Garetosmab
Arm C0
Experimental group
Description:
Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Garetosmab
Drug: Matching Placebo-Trevogrumab
Arm C1
Experimental group
Description:
Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Garetosmab
Arm D0
Experimental group
Description:
Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Garetosmab
Drug: Matching Placebo-Trevogrumab
Arm D1
Experimental group
Description:
Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Garetosmab
Arm 1
Experimental group
Description:
Part C Sema and SC placebo Randomized 1:2:2
Treatment:
Drug: Semaglutide
Drug: Matching Placebo-Trevogrumab
Arm 2
Experimental group
Description:
Part C Sema and SC low dose trevo Randomized 1:2:2
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Trevogrumab
Arm 3
Experimental group
Description:
Part C Sema and SC moderate dose trevo Randomized 1:2:2
Treatment:
Drug: Semaglutide
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Trevogrumab

Trial contacts and locations

59

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Central trial contact

Clinical Trials Administrator

Data sourced from clinicaltrials.gov

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