Effect of (S)-Pindolol Benzoate (ACM-001.1) on lean body mass during and after semaglutide treatment in people with obesity
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)
This test will try whether ACM-001.1 (S‑pindolol benzoate) can reduce muscle loss during semaglutide treatment and help people with obesity regain muscle after stopping semaglutide.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Actimed Therapeutics Ltd Industry-sponsored |
| Locations | 7 sites (Belgrade and 6 other locations) |
| Trial ID | NCT07101939 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with obesity (BMI ≥30 kg/m²) who are eligible for semaglutide treatment and meet the study's health and medication criteria are the intended participants.
Not a fit: Patients with recent GLP-1RA use, recent major cardiovascular events, uncontrolled hypertension, severe COPD, contraindications to beta blockers, or certain unstable type 2 diabetes profiles are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, ACM-001.1 could help preserve or restore lean body mass in people using semaglutide, reducing muscle loss and improving strength and function.
How similar studies have performed: Semaglutide is known to cause weight loss with some accompanying lean mass loss, and limited prior work with pindolol-type agents suggests potential to preserve lean mass, but using ACM-001.1 alongside and after semaglutide is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Belgrade and 6 other locations
- 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)
- Opsta bolnica Pancevo — Pančevo, Serbia (Recruiting)
Study contacts
- Study coordinator: Fabio Dorigotti, MD
- Email: info@actimedtherapeutics.com
- Phone: +41 79 653 55 67
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.