RecruitingPhase 2

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)

Serbia120 participantsStarted 2025-06-23

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide.

Timeframe: 20 weeks

The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment.

Timeframe: 20 weeks

Trial details

NCT IDNCT07101939

SponsorActimed Therapeutics Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Fabio Dorigotti, MD

+41 79 653 55 67 info@actimedtherapeutics.com