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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)

RecruitingPhase 2Ages 18 Years - 75 YearsAllActimed Therapeutics Ltd
NCT07101939 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Key Inclusion Criteria: Eligible for treatment with semaglutide. Have a BMI of ≥30.0 kg/m². Key Exclusion Criteria: Type 2 diabetes mellitus who in the preceding 90 days have either: * received a GLP-1RA (including semaglutide), * had a hypoglycaemic event, * lost \>5 kg weight, * had a HBA1C over 10.0%. Any cardiovascular event within previous 6 months, uncontrolled hypertension, known congestive heart failure, or angina during the past year Known severe chronic obstructive pulmonary disease (COPD) Concomitant use of beta blockers and patients with contra indications to beta blockers
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What it tests

  • (S)-pindolol benzoate
  • Semaglutide
  • Placebo to (S)-pindolol benzoate
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Where

7 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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