Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

It had five arms (groups): Nimacimab injection (experimental), Nimacimab placebo injection (placebo comparator), one (experimental), Semaglutide injection + Nimacimab placebo injection (active comparator) and one (experimental).

Matching nimacimab placebo injection.

The registry classes the interventions as biological and combination product.

More on the Plan

A study extension has been added to include additional 26 weeks of treatment and 13 weeks of follow up for qualifying participants starting May2025.

Who Took Part

136 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Male, female, and/or nonbinary participants. Have Body Mass Index (BMI) of. ≥ 30 kg/m2 to ≤ 45 kg/m2 OR. ≥ 27 kg/m2 and \< 30 kg/m2 with clinically confirmed diagnosis of at least 1 of the following weight-related co-morbidities:.

The full record lists 16 inclusion and 44 exclusion criteria; among the exclusions: have any prior diagnosis of type 1 or type 2 diabetes mellitus (t1dm or t2dm, or rare forms of diabetes mellitus); have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \> 1 year prior to screening); have had at any time or plan to have endoscopic and/or device-based therapy for obesity including but not limited to the following:.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

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

It started in 2024-08-22 with completion listed for 2026-11-20.

It ran at 16 sites in United States (16).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent change in body weight (main study) (time frame: From Baseline to Week 26). Nature, frequency and severity of AEs (study extension) (time frame: Baseline through Week 38 of study extension (approximately 10 months of participation)).

It also tracked 9 secondary outcomes, for example Change in body weight (main study), Change in waist circumference (main study), Change in waist circumference (study extension), Change in lean versus fat mass ratio measured by DXA (main study), Change in lean versus fat mass ratio measured by DXA (study extension) and Change in BMI (main study).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 136 people.

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, all human trials.