A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)

What Was Tested

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

Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients.

The purpose of this study is to investigate the effect of ACM-001.1 (the study drug) on how much muscle is lost when a person takes it with semaglutide (PROACT 1) and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide (PROACT 2).

It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study will compare the effects of ACM-001.1 (the study drug) when it is taken at the same time as semaglutide, and after semaglutide treatment has stopped.

To allow the measurement of the effect of each treatment type, the study will involve the use of a placebo tablet and a 'sham' (fake) injection of semaglutide.

Various tests will be used to measure the effect of the study drug.

These will include a DEXA scan (like an X-ray).

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

The full record lists 0 inclusion and 4 exclusion criteria; among the exclusions: received a glp-1ra (including semaglutide),; had a hypoglycaemic event,; lost \>5 kg weight,.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Semaglutide.

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

It started in 2025-06-23 with completion listed for 2027-03.

It ran at 7 sites in Serbia (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment (time frame: 20 weeks).

It also tracked 2 secondary outcomes, for example Changes in fat mass during and following semaglutide treatment and Muscle Strength (Handgrip strength) during and following semaglutide treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 120 people with fat loss, obesity & body recomposition.

It is still 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.