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)

NCT07101939 | Recruiting Phase 2

• 1 other identifier: ACM-001-2024-01-CT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Obesity; Muscle Loss

Keywords

semaglutide; s-pindolol; obesity; glp-1; glucagon-like peptide-1 receptor agonist; lean body mass

Outcome Measures

Primary Outcomes (2)

• The change in lean body mass (LBM) in patients receiving one of two doses of ACM-001.1 whilst also receiving semaglutide.

  In Arms 1 and 2: The change in lean body mass (LBM) grams/4 weeks over 20 weeks comparing 2 doses of ACM-001.1 with placebo. Body composition parameters will be measured using Dual Energy X-ray absorptiometry (DEXA) scan.

  20 weeks

• The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment.

  In Arm 3: The change in lean body mass (LBM) grams/4 weeks over 20 weeks comparing 2 doses of ACM-001.1 with placebo. Body composition parameters will be measured using Dual Energy X-ray absorptiometry (DEXA) scan.

  20 weeks

Secondary Outcomes (2)

• Changes in fat mass during and following semaglutide treatment

  20 weeks

• Muscle Strength (Handgrip strength) during and following semaglutide treatment

  20 weeks

Other Outcomes (13)

• An evaluation of changes in body weight during and following semaglutide treatment

  20 weeks

• Change in lean body mass (LBM) at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo

  20 weeks

• Evaluation of hip:waist ratio during and following semaglutide treatment

  20 weeks

Study Arms (3)

Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1

ACTIVE COMPARATOR

Patients in Arm 1 will be randomized to a crossover design, to receive either semaglutide and low dose ACM-001.1 BID or a sham injection and placebo ACM-001.1 BID during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.

Drug: (S)-pindolol benzoate; Drug: Semaglutide; Drug: Placebo to (S)-pindolol benzoate

Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1

ACTIVE COMPARATOR

Patients in Arm 2 will be randomized to a crossover design, to receive either semaglutide and high dose ACM-001.1 BID (Group 2a) or a sham injection and placebo ACM-001.1 BID (Group 2b) during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.

Drug: (S)-pindolol benzoate; Drug: Semaglutide; Drug: Placebo to (S)-pindolol benzoate

Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2

ACTIVE COMPARATOR

Patients randomized to Arm 3 will receive semaglutide and placebo ACM-001.1 BID during Period 1. Patients in Arm 3 will be further randomised into one of three treatment groups for Period 2: Group 3a will receive a sham injection and low dose ACM-001.1 BID Group 3b will receive a sham injection and high dose ACM-001.1 BID Group 3c will receive a sham injection and Placebo ACM-001.1 BID

Drug: (S)-pindolol benzoate; Drug: Semaglutide; Drug: Placebo to (S)-pindolol benzoate

Interventions

(S)-pindolol benzoate DRUG

(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.

Also known as: ACM-001.1

Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2

Semaglutide DRUG

Semaglutide, solution for injection in pre-filled pen

Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2

Placebo to (S)-pindolol benzoate DRUG

Placebo to ACM-001.1 immediate release tablet administered BID

Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1; Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actimed Therapeutics Ltd: lead
• SCIRENT Clinical Research and Science d.o.o.: collaborator

Study Sites (7)

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

MeSH Terms

Conditions

Obesity; Muscular Atrophy

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Fabio Dorigotti, MD

CONTACT

+41 79 653 55 67; info@actimedtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-part, randomized, part parallel-group, double-blind placebo-controlled cross-over multi-center study

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 3, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

SE (7)