Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

What Was Tested

The trial (phase 2) is built around Semaglutide and Bimagrumab.

It had nine arms (groups): one (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as biological, drug and other.

Who Took Part

The registry lists 507 actual participants took part.

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

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

Examples of who could join: A written informed consent must be obtained before any study-related assessments are performed. Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:. Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia). Stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg. Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: history of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (ozempic® or wegovy®); treatment with any medication for the indication of obesity within the past 30 days before screening.

How the Study Was Run

The set-up was randomized, factorial and double-blind.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2022-11-16 with completion listed for 2024-05-16.

It ran at 26 sites in United States (10), Australia (8) and New Zealand (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Body Weight at Week 48 (time frame: Baseline, Week 48).

It also tracked 41 secondary outcomes, for example Change From Baseline in Waist Circumference at Week 48, Change From Baseline in Waist Circumference at Week 72, Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48, Change From Baseline in Total Body Fat Mass in kg at Week 72, Percent Change From Baseline for Fat Mass by DXA at Week 48 and Percent Change From Baseline for Fat Mass by DXA at Week 72.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide and Bimagrumab in 507 people.

With 507 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page and the Bimagrumab compound page, all human trials.