ObesityPhase 2PROACTNCT07101939
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 Phase 2 study testing (S)-pindolol benzoate and Semaglutide in people with Obesity and Muscle Loss, run by Actimed Therapeutics Ltd at 7 sites in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Muscle Loss
- What is being tested?
- (S)-pindolol benzoate and Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesSerbia
- Study dates
- 23 Jun 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for treatment with semaglutide.
- Have a BMI of ≥30.0 kg/m².
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Serbia7 sites, 7 recruiting
- Recruiting
Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'
Belgrade
Vladan Vukomanovic, Dr.
- Recruiting
Clinical Hospital Center Bezanijska kosa
Belgrade
Marija Zdravkovic, Prof. Dr.
Marija Zdravkovic, Prof. Dr
- Recruiting
University Clinical Center of Serbia
Belgrade
Vesna Dimitrijevic Sreckovic, Prof. Dr.
- Recruiting
University Clinical Center Kragujevac
Kragujevac
Miodrag Sreckovic, Dr.
- Recruiting
Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma
Niš
Sasa Radenkovic, Dr.
- Recruiting
University Clinical Center of Vojvodina
Novi Sad
Milena Mitrovic, Prof. Dr.
- Recruiting
Opsta bolnica Pancevo
Pančevo
Ana Kovacevic Kuzmanovic, Dr.
About this study
Official 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)
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).
Read the detailed description
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.
- Conditions
- Obesity, Muscle Loss
- Being tested
- (S)-pindolol benzoate, Semaglutide, Placebo to (S)-pindolol benzoate
- Keywords
- semaglutide, s-pindolol, obesity, glp-1, glucagon-like peptide-1 receptor agonist, lean body mass
- Medical subject headings
- Obesity, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(S)-pindolol benzoateDrug
Also called ACM-001.1
(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.
SemaglutideDrug
Semaglutide, solution for injection in pre-filled pen
Placebo to (S)-pindolol benzoateDrug
Placebo to ACM-001.1 immediate release tablet administered BID
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: (S)-pindolol benzoate; Drug: Semaglutide; Drug: Placebo to (S)-pindolol benzoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20 weeks
Secondary outcomes (2)
Changes in fat mass during and following semaglutide treatment
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.
Measured: 20 weeks
Muscle Strength (Handgrip strength) during and following semaglutide treatment
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.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start23 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A two-part, randomized, part parallel-group, double-blind placebo-controlled cross-over multi-center study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actimed Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SCIRENT Clinical Research and Science d.o.o.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101939
- Sponsor's protocol ID
- ACM-001-2024-01-CT
- Acronym
- PROACT
- Status last verified
- Feb 2026
- First submitted
- 20 Jun 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07101939
- Acronym / sponsor ID
- PROACT / ACM-001-2024-01-CT
- Conditions
- Obesity, Muscle Loss
- Keywords
- semaglutide, s-pindolol, obesity, glp-1, glucagon-like peptide-1 receptor agonist, lean body mass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Actimed Therapeutics LtdIndustry (pharma, biotech, devices)
- Collaborators
- SCIRENT Clinical Research and Science d.o.o.
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A two-part, randomized, part parallel-group, double-blind placebo-controlled cross-over multi-center study
| Arm | Type | Receives |
|---|---|---|
| Arm 1 semaglutide, low dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1 | Active comparator | Drug: (S)-pindolol benzoate, Drug: Semaglutide, Drug: Placebo to (S)-pindolol benzoatePatients 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. |
| Arm 2 semaglutide, high dose ACM-001.1 or sham injection/placebo during semaglutide therapy PROACT 1 | Active comparator | Drug: (S)-pindolol benzoate, Drug: Semaglutide, Drug: Placebo to (S)-pindolol benzoatePatients 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. |
| Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2 | Active comparator | Drug: (S)-pindolol benzoate, Drug: Semaglutide, Drug: Placebo to (S)-pindolol benzoatePatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible for treatment with semaglutide.
- Have a BMI of ≥30.0 kg/m².
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (S)-pindolol benzoateAlso: ACM-001.1(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID. | Drug | 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 |
| SemaglutideSemaglutide, solution for injection in pre-filled pen | Drug | 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 benzoatePlacebo to ACM-001.1 immediate release tablet administered BID | Drug | 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 |
Primary outcome
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.
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.
2 secondary outcomes
Changes in fat mass during and following semaglutide treatment
Time frame: 20 weeks
Muscle Strength (Handgrip strength) during and following semaglutide treatment
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing (S)-pindolol benzoate and Semaglutide in people with Obesity and Muscle Loss, run by Actimed Therapeutics Ltd at 7 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Dorigotti, MD (+41 79 653 55 67, info@actimedtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.