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NCT07101939RecruitingPhase 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)

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)

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
First submitted
20 Jun 2025
Start date
23 Jun 2025
Primary completion date
Mar 2027
Lead sponsor
Actimed Therapeutics Ltd
Diseases
Obesity
NCT number
NCT07101939

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 120
  • From 23 Jun 2025 to the primary completion date, Mar 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • received a GLP-1RA (including semaglutide),

Other illness

  • Type 2 diabetes mellitus who in the preceding 90 days have either:

Lab values

  • 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

Other

  • had a hypoglycaemic event,
  • lost \>5 kg weight,

Who the study is looking for

  • Eligible for treatment with semaglutide.
  • Have a BMI of ≥30.0 kg/m².

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical hospital center Bezanijska Kosa
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
University Clinical Center of Serbia
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BelgradeSerbiaRecruiting
University Clinical Center Kragujevac
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KragujevacSerbiaRecruiting
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
Coordinator of this site? Confirm its status
NišSerbiaRecruiting
University Clinical Center of Vojvodina
Coordinator of this site? Confirm its status
Novi SadSerbiaRecruiting
Opsta bolnica Pancevo
Coordinator of this site? Confirm its status
PančevoSerbiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.