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

What Was Tested

This registered phase 2 trial tested Semaglutide for fat loss, obesity & body recomposition.

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.

It had 13 arms (groups): Placebo (placebo comparator), Trevogrumab (experimental), Arm A0 (experimental), Arm A1 (experimental) and Arm B0 (experimental).

Part A Randomized 1:1.

Part A Randomized 1:1.

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.

The registry classes the interventions as drug.

More on the Plan

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

Who Took Part

The registry lists 1005 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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. 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, sequential and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-03-13 with completion listed for 2026-06-16.

It ran at 60 sites in United States (58) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of treatment-emergent adverse events (TEAEs) (time frame: Baseline to week 7). Severity of TEAEs (time frame: Baseline to week 7). Percent change in total fat mass (time frame: Baseline to week 26).

It also tracked 21 secondary outcomes, for example Concentrations of trevogrumab in serum over time, Percent change in total fat mass, Percent change in total lean mass, Percent change in body weight, Change in waist circumference (cm) and Change in waist circumference (cm).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 1005 people with fat loss, obesity & body recomposition.

With 1005 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.