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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Obesity trials