Effect of (S)-Pindolol Benzoate (ACM-001.1) on lean body mass during and after semaglutide treatment in people with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind Phase 2 trial enrolls adults with obesity to receive one of two oral doses of ACM-001.1 or matching placebo while either concurrently receiving weekly semaglutide (PROACT 1) or after semaglutide treatment has stopped (PROACT 2). The overall program has two 20-week treatment periods separated by a 4-week washout, and includes a sham injection to preserve blinding for semaglutide exposure. Outcomes include changes in lean body mass measured by DEXA, body weight, cardiac and muscle function tests, patient-reported health questionnaires, and blood biomarkers. Two oral dose levels of ACM-001.1 are compared against placebo while weekly semaglutide or sham injections are administered to allow measurement of combined and post‑semaglutide effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
  Belgrade, Serbia Recruiting
• Clinical Hospital Center Bezanijska kosa
  Belgrade, Serbia Recruiting
• University Clinical Center of Serbia
  Belgrade, Serbia Recruiting
• University Clinical Center Kragujevac
  Kragujevac, Serbia Recruiting
• Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
  Niš, Serbia Recruiting
• University Clinical Center of Vojvodina
  Novi Sad, Serbia Recruiting

Study contacts

• Study coordinator: Fabio Dorigotti, MD
• Email: info@actimedtherapeutics.com
• Phone: +41 79 653 55 67

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.