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NCT Number: NCT07101939

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)

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

The study will compare the effects of ACM-001.1 (the study drug) when it is taken at the same time as semaglutide, and after semaglutide treatment has stopped. To allow the measurement of the effect of each treatment type, the study will involve the use of a placebo tablet and a 'sham' (fake) injection of semaglutide.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(S)-pindolol benzoate

Drug

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

Other names: ACM-001.1

semaglutide

Drug

Semaglutide, solution for injection in pre-filled pen

Placebo to (S)-pindolol benzoate

Drug

Placebo to ACM-001.1 immediate release tablet administered BID

Primary outcomes

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

    Time frame: 20 weeks

    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.

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

    Time frame: 20 weeks

    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.

Secondary outcomes

  1. Changes in fat mass during and following semaglutide treatment

    Time frame: 20 weeks

    In Arms 1 & 2: The change in fat mass (grams/4 weeks) over 20 weeks during semaglutide treatment comparing 2 doses of ACM-001.1 with placebo will be measured by DEXA scan.

    In Arm 3: The change in fat mass (grams/4 weeks) following semaglutide therapy comparing 2 doses of ACM-001.1 with placebo will be measured by DEXA scan.

  2. Muscle Strength (Handgrip strength) during and following semaglutide treatment

    Time frame: 20 weeks

    In Arms 1 & 2: The change in Handgrip strength (kg/100g of arm lean mass) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: The change in Handgrip strength (kg/100g of arm lean mass) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

Other outcomes

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

    Time frame: 20 weeks

    In Arms 1 & 2: An evaluation of changes in body weight (kg/4 weeks) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in body weight (kg/4 weeks) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

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

    Time frame: 20 weeks

    In Arm 3: The change in lean body mass (LBM) (g/4 weeks) after completing a period of 20 weeks of semaglutide therapy (plus placebo) comparing 2 doses of ACM-001.1 with placebo

  3. Evaluation of hip:waist ratio during and following semaglutide treatment

    Time frame: 20 weeks

    In Arms 1 & 2: An evaluation of changes in hip:waist ratio (each circumference measured in cm) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in hip:waist ratio (each circumference measured in cm) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  4. Change in body composition (bone mineral composition) during and following semaglutide treatment

    Time frame: 20 weeks

    In Arms 1 & 2: An evaluation of changes in body composition (bone mineral composition (grams/4 weeks)) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in body composition (bone mineral composition (grams/4 weeks)) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  5. Change in body composition (regional lean body mass) during and following semaglutide treatment

    Time frame: 20 Weeks

    In Arms 1 & 2: An evaluation of changes in body composition (regional lean body mass (expressed as grams/4 weeks)) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in body composition (total and regional lean body mass (expressed as grams/4 weeks)) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  6. Evaluation of functional capacity (muscle strength) by stair climbing power (SCP)

    Time frame: 20 weeks

    In Arms 1 & 2: An evaluation of changes in functional capacity (muscle strength) by SCP (SCP/kg) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in functional capacity (muscle strength) by SCP (SCP/kg) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  7. Evaluation of functional capacity (muscle strength) by six minute walk test (6MWT)

    Time frame: 20 Weeks

    In Arms 1 & 2: An evaluation of changes in functional capacity (muscle strength) 6MWT (meters/6 minutes) as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of changes in functional capacity (muscle strength) 6MWT (meters/6 minutes) as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  8. An evaluation of heart rate (beats/minute) during and following semaglutide treatment

    Time frame: 20 weeks

    In Arms 1 & 2: Heart rate in beats/minute as the change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: Heart rate in beats/minute as the change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  9. An evaluation of electrocardiogram (ECG) abnormalities as change from baseline during and following semaglutide treatment

    Time frame: 20 Weeks

    In Arms 1 & 2: A 12-lead electrocardiogram (ECG) will be performed. The ECG will be reviewed by the Investigator or a qualified designee for abnormalities as change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. Any medically significant changes from the baseline ECG will be recorded as an AE.

    In Arm 3: A 12-lead ECG will be performed. The ECG will be reviewed by the Investigator or a qualified designee for abnormalities as change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo. Any medically significant changes from the baseline ECG will be recorded as an AE.

  10. An evaluation of echocardiogram abnormalities as change from baseline during and following semaglutide treatment

    Time frame: 20 Weeks

    In Arms 1 & 2: An echocardiogram will be performed during the study. The results will be reviewed for abnormalities as change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo. The Investigator responsible for performing the echocardiogram will review the data. Any medically significant changes from the baseline will be recorded as an AE.

    In Arm 3: An echocardiogram will be performed during the study. The results will be reviewed for abnormalities as change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo. Any medically significant changes from the baseline will be recorded as an AE.

    On assessment the following data will be collected: left ventricular ejection fraction (LVEF), left ventricular global longitudinal strain (GS), left ventricular end-diastolic diameter (LVEDD), left atrial diameter (LAD) and absolute left ventricular mass (LV mass).

  11. Evaluation of patient reported outcomes during and following semaglutide treatment (quality of life)

    Time frame: 20 weeks

    In Arms 1 & 2: An evaluation of patient reported quality of life assessment by questionnaire as change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of patient reported quality of life assessment by questionnaire as change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  12. Evaluation of patient reported outcomes during and following semaglutide treatment (patient well being)

    Time frame: 20 Weeks

    In Arms 1 & 2: An evaluation of patient reported global assessment of subjective well-being by questionnaire as change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of patient reported global assessment of subjective well-being by questionnaire as change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

  13. Evaluation of patient reported outcomes during and following semaglutide treatment (appetite)

    Time frame: 20 Weeks

    In Arms 1 & 2: An evaluation of patient reported appetite using a visual analogue appetite scale as change from baseline (Period 1) over 20 weeks comparing 2 doses of ACM-001.1 with placebo.

    In Arm 3: An evaluation of patient reported appetite using a visual analogue appetite scale as change from baseline at the end of semaglutide therapy comparing 2 doses of ACM-001.1 with placebo.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Dorigotti, MD

CONTACT

[email protected]

+41 79 653 55 67

Sponsors and collaborators

Lead sponsor

Actimed Therapeutics Ltd

Industry

Collaborators

  • SCIRENT Clinical Research and Science d.o.o.

Registry information

Official study title

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)

Acronym: PROACT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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