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

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: Matching Placebo-Garetosmab; Drug: Garetosmab; Drug: Matching Placebo-Part A; Drug: Matching Placebo-Trevogrumab; Drug: Trevogrumab-Part A; Drug: Semaglutide; Drug: Trevogrumab-Part B

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®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B 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 of the study is to see how safe and effective the study drug is when combined with Wegovy.

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

Enrollment: 624 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

3. Male or female participants ≥18 to ≤80 years of age at the time of screening

4. BMI ≥30 kg/m2

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 3 months 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

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624 participants in 10 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-Trevogrumab

Drug: Matching Placebo-Garetosmab

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

Drug: Matching Placebo-Trevogrumab

Drug: Matching Placebo-Garetosmab

Arm B0

Experimental group

Description:

Part B Sema, low 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

Drug: Matching Placebo-Trevogrumab

Drug: Matching Placebo-Garetosmab

Arm B1

Experimental group

Description:

Part B Sema, low 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

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

Drug: Matching Placebo-Trevogrumab

Drug: Matching Placebo-Garetosmab

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

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

Drug: Matching Placebo-Trevogrumab

Drug: Garetosmab

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

Drug: Garetosmab