Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Part A Randomized 1:1
  • Drug: Matching Placebo-Part A
    Administered IV or SC in Part A
Experimental
Trevogrumab
Part A Randomized 1:1
  • Drug: Trevogrumab-Part A
    Administered IV or SC in Part A
    Other names:
    • REGN1033
    • GDF8
Experimental
Arm A0
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
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm A1
Part B Sema and SC placebo and IV placebo followed by high dose trevogrumab (trevo) Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm B0
Part B Sema, moderate-high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm B1
Part B Sema, moderate-high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm C0
Part B Sema, high dose trevo, and IV placebo followed by SC placebo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm C1
Part B Sema, high dose trevo, and IV placebo followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Garetosmab
    Administered IV in Part B
Experimental
Arm D0
Part B Sema, high dose trevo, and garetosmab (gareto) followed by SC placebo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Garetosmab
    Administered IV in Part B
    Other names:
    • REGN2477
    • Activin A
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
Experimental
Arm D1
Part B Sema, high dose trevo, and gareto followed by high dose trevo Randomized 1:1:1:1:1:1:1:1
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Garetosmab
    Administered IV in Part B
    Other names:
    • REGN2477
    • Activin A
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
Experimental
Arm 1
Part C Sema and SC placebo Randomized 1:2:2
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
Experimental
Arm 2
Part C Sema and SC low dose trevo Randomized 1:2:2
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®
  • Drug: Matching Placebo-Trevogrumab
    Administered SC in Part B and Part C
Experimental
Arm 3
Part C Sema and SC moderate dose trevo Randomized 1:2:2
  • Drug: Trevogrumab-Part B and Part C
    Administered SC in Part B, Part C
    Other names:
    • REGN1033
    • GDF8
  • Drug: Semaglutide
    Administered SC in Part B and Part C
    Other names:
    • Wegovy®

Recruiting Locations

More Details

NCT ID
NCT06299098
Status
Active, not recruiting
Sponsor
Regeneron Pharmaceuticals

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.