Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese

What Was Tested

The trial (phase 2) is built around Tirzepatide.

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity.

It had two arms (groups): Cohort 1 (experimental) and Cohort 2 (placebo comparator).

Apitegromab + incretin mimetic.

Placebo + incretin mimetic.

The registry classes the interventions as drug.

More on the Plan

Each subject received tirzepatide throughout the treatment period.

In addition, all subjects were randomized 1:1 to receive either apitegromab or placebo during the treatment period.

Who Took Part

The registry lists 102 actual participants took part.

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

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

Examples of who could join: Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent. Stable body weight (±5 kg) within 90 days of Screening. At Screening, a BMI of:. ≥30.0 kg/m2 to ≤45.0 kg/m2 or. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: history of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease; active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas; history of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.

How the Study Was Run

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

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Tirzepatide 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 2024-05-21 with completion listed for 2025-03-04.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline in total Lean Body Mass (kg) at 24 weeks (time frame: Baseline and 24 weeks).

It also tracked 10 secondary outcomes, for example Change from Baseline in body weight, Change from Baseline in percent lean body mass (%), Change from Baseline in fat body mass (kg and %), Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %), Percent (%) of weight loss from baseline due to fat body mass loss and Percent (%) of weight loss from baseline due to lean body mass loss.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 102 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.