RecruitingPhase 2NCT07101939

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)

A Two-part, Phase 2a Randomized, Part Parallel-group, Double-blind Placebo-controlled Cross-over Multi-center Study to Evaluate the Effect of Two Dose Levels of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass in Obese Patients During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)


Sponsor

Actimed Therapeutics Ltd

Enrollment

120 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called (S)-pindolol benzoate, a drug called Placebo to (S)-pindolol benzoate, and others for people with muscle loss and obesity. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG(S)-pindolol benzoate

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

DRUGSemaglutide

Semaglutide, solution for injection in pre-filled pen

DRUGPlacebo to (S)-pindolol benzoate

Placebo to ACM-001.1 immediate release tablet administered BID


Locations(7)

Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'

Belgrade, Serbia

Clinical Hospital Center Bezanijska kosa

Belgrade, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

University Clinical Center Kragujevac

Kragujevac, Serbia

Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma

Niš, Serbia

University Clinical Center of Vojvodina

Novi Sad, Serbia

Opsta bolnica Pancevo

Pančevo, Serbia

View Full Details on ClinicalTrials.gov

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NCT07101939


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