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)
NCT ID: NCT07101939
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-06-23
2027-03-31
Brief Summary
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Detailed Description
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Various tests will be used to measure the effect of the study drug. These will include a DEXA scan (like an X-ray). The study will also include measurements of weight, tests on the heart, and tests of muscle function. Questionnaires relating to health and well-being will also be used. Blood samples will be taken and tested to check overall health.
The study takes place in two parts, each lasting 20 weeks. Between each 20-week period) there is a 4-week 'wash-out' period during which patients will not receive any treatment.
ACM-001.1 (or placebo) is a tablet for oral administration (by mouth). Two doses of ACM-001.1 are being tested in this study. The semaglutide or sham injection will be administered once every week.
The study is 'double-blind', neither the patient or the doctor will know if the patient is taking ACM-001.1 or placebo or which dose they receive.
The total study is expected to run for approximately 18 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1
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.
(S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1
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.
(S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2
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
(S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Interventions
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(S)-pindolol benzoate
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
Semaglutide
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoate
Placebo to ACM-001.1 immediate release tablet administered BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Have a BMI of ≥30.0 kg/m².
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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SCIRENT Clinical Research and Science d.o.o.
UNKNOWN
Actimed Therapeutics Ltd
INDUSTRY
Responsible Party
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Locations
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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
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
Niš, , Serbia
University Clinical Center of Vojvodina
Novi Sad, , Serbia
Opsta bolnica Pancevo
Pančevo, , Serbia
Opsta bolnica Valjevo
Valjevo, , Serbia
Countries
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Central Contacts
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Facility Contacts
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Vladan Vukomanovic, Dr.
Role: primary
Marija Zdravkovic, Prof. Dr.
Role: primary
Vesna Dimitrijevic Sreckovic, Prof. Dr.
Role: primary
Miodrag Sreckovic, Dr.
Role: primary
Sasa Radenkovic, Dr.
Role: primary
Milena Mitrovic, Prof. Dr.
Role: primary
Ana Kovacevic Kuzmanovic, Dr.
Role: primary
Katarina Odanovic, Dr.
Role: primary
Other Identifiers
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ACM-001-2024-01-CT
Identifier Type: -
Identifier Source: org_study_id