Clinical trial

A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects

Name

SRK-015-006

Description

A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight or obesity

Trial arms

Trial start

2024-05-21

Estimated PCD

2025-06-30

Trial end

2025-10-20

Status

Recruiting

Phase

Early phase I

Treatment

Apitegromab

Apitegromab (SRK-015) is a fully human anti-proMyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab will be administered every 4 weeks by intravenous (IV) infusion.

Arms:

Cohort 1

Other names:

SRK-015

Placebo

Same appearance and composition as apitegromab drug product but does not contain the active ingredient. Placebo will be administered every 4 weeks by intravenous (IV) infusion.

Arms:

Cohort 2

Semaglutide

Glucagon-like peptide-1 (GLP-1) receptor agonist. Semaglutide will be administered every week by subcutaneous injection.

Arms:

Cohort 1, Cohort 2

Other names:

WEGOVY

Tirzepatide

Glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Tirzepatide will be administered every week by subcutaneous injection.

Arms:

Cohort 1, Cohort 2

Other names:

ZEPBOUND

Size

100

Primary endpoint

Change from Baseline in total Lean Body Mass (kg) at 24 weeks

Baseline and 24 weeks

Eligibility criteria

Inclusion Criteria * Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments * Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent * Stable body weight (±5 kg) within 90 days of Screening * At Screening, a BMI of: 1. ≥30.0 kg/m2 to ≤45.0 kg/m2 or 2. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See exclusion criteria for specific organ class disease parameters Exclusion Criteria: * History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease * Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas * History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening * History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred \>12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Active treatment, randomized, double-blind, placebo-controlled', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-06-06

1 organization

3 products

1 drug

1 indication

Organization

Product

Indication

Drug

Product

Product