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)

ConditionsObesity Muscle Loss

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorActimed Therapeutics Ltd

About this trial

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).

Eligibility criteria

Qualifiers

None

Disqualifiers

received a GLP-1RA (including semaglutide),

had a hypoglycaemic event,

lost >5 kg weight,

had a HBA1C over 10.0%.

Trial design

Treatments tested in this trial

(S)-pindolol benzoate
Semaglutide
Placebo to (S)-pindolol benzoate

Treatment groups

120 Participants

are divided into 3 treatment groups

Locations

Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje' Belgrade Serbia

Clinical Hospital Center Bezanijska kosa Belgrade Serbia

University Clinical Center of Serbia Belgrade Serbia

University Clinical Center Kragujevac Kragujevac Serbia

Sponsors and collaborators

Actimed Therapeutics Ltd

Lead sponsor

SCIRENT Clinical Research and Science d.o.o.

Collaborator

Source ClinicalTrials.gov