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)

NCT07101939 · Recruiting

Last updated 2026-05-28

This study is testing whether two different doses of the drug ACM-001.1, when taken with semaglutide, can help maintain or increase muscle mass in adults who are obese.

Status Recruiting Currently enrolling participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 120 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2025-06 · est. completion 2027-03

Where 7 sites · Serbia

What this study is testing ClinicalTrials.gov NCT07101939 ↗

Description as written by the study sponsor.

Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients. Drug treatments like semaglutide that result in weight-loss can also decrease muscle mass. 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).

Treatments tested

(S)-pindolol benzoate also known as ACM-001.1 Drug

(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide Drug

Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate Drug

Placebo to ACM-001.1 immediate release tablet administered BID

Main thing measured	The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide.
Sponsor	Actimed Therapeutics Ltd
Conditions studied	Obesity, Muscle Loss
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07101939 ↗