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PROACT
RecruitingPhase 2A 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 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)
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Semaglutide
Listed sites
7
Recruiting sites
7
Enrollment
120
estimated
Study population
Obesity / overweight, Sarcopenia / muscle
Key I/E criterion
•BMI ≥30
Primary endpoint
•Lean mass
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
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:
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
Endpoints (17)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
9 endpointsThe 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
Lean mass
change from baseline, improvement
The change in lean body mass (LBM) grams/4 weeks over 20 weeks following semaglutide treatment.
Time frame:20 weeks
Lean mass
change from baseline, improvement
Changes in fat mass during and following semaglutide treatment
Time frame:20 weeks
Total fat mass
change from baseline, improvement
Muscle Strength (Handgrip strength) during and following semaglutide treatment
Time frame:20 weeks
change from baseline, improvement
An evaluation of changes in body weight during and following semaglutide treatment
Time frame:20 weeks
Body weight, absolute change (kg)
change from baseline, improvement
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
Lean mass
change from baseline, improvement
Evaluation of hip:waist ratio during and following semaglutide treatment
Time frame:20 weeks
change from baseline, improvement
Change in body composition (bone mineral composition) during and following semaglutide treatment
Time frame:20 weeks
change from baseline, descriptive
Change in body composition (regional lean body mass) during and following semaglutide treatment
Time frame:20 Weeks
Lean mass
change from baseline, improvement
Heart failure
1 endpointEvaluation of functional capacity (muscle strength) by six minute walk test (6MWT)
Time frame:20 Weeks
6-minute walk distance
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointAn evaluation of heart rate (beats/minute) during and following semaglutide treatment
Time frame:20 weeks
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
3 endpointsEvaluation of patient reported outcomes during and following semaglutide treatment (quality of life)
Time frame:20 weeks
change from baseline, improvement
Evaluation of patient reported outcomes during and following semaglutide treatment (patient well being)
Time frame:20 Weeks
PGI, change
change from baseline, improvement
Evaluation of patient reported outcomes during and following semaglutide treatment (appetite)
Time frame:20 Weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointsAn evaluation of electrocardiogram (ECG) abnormalities as change from baseline during and following semaglutide treatment
Time frame:20 Weeks
change from baseline, descriptive
An evaluation of echocardiogram abnormalities as change from baseline during and following semaglutide treatment
Time frame:20 Weeks
change from baseline, descriptive
Other clinical outcomes
1 endpointEvaluation of functional capacity (muscle strength) by stair climbing power (SCP)
Time frame:20 weeks
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.