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

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Trevogrumab-Part A — DRUG
  Administered IV or SC in Part A
• Trevogrumab-Part B and Part C — DRUG
  Administered SC in Part B, Part C
• Garetosmab — DRUG
  Administered IV in Part B
• Semaglutide — DRUG
  Administered SC in Part B and Part C
• 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

Study Details

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)

Key Dates

Start date

Mar 13, 2024

Status verified

May 2026

Primary completion

May 18, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

1,005 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Part A Randomized 1:1
• Experimental: Trevogrumab
  Part A Randomized 1:1
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Experimental: Arm 1
  Part C Sema and SC placebo Randomized 1:2:2
• Experimental: Arm 2
  Part C Sema and SC low dose trevo Randomized 1:2:2
• Experimental: Arm 3
  Part C Sema and SC moderate dose trevo Randomized 1:2:2

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to week 7 ]

Locations (58)

Find similar trials in Anniston, AL

Related Studies

• Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
  PHASE2 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phoenix, Arizona
• Investigating the Impact of Obesity on Pubertal Development in Girls
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• Metabolic Effects of Angiotensin-(1-7)
  PHASE1 · Recruiting · Vanderbilt University · Nashville, Tennessee
• Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis
  Not Yet Recruiting · Keith Pereira, MD: · St Louis, Missouri