Clinical trial NCT06445075: Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Overweight and Obesity
Keywords: Overweight
Obesity
Lead sponsor: Scholar Rock, Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This phase 2 randomized, double-blind, placebo-controlled, multicenter study will assess the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 agonist therapy in subjects with overweight and obesity and without diabetes. Each subject will receive either semaglutide or tirzepatide, depending upon availability, and will maintain that course throughout the treatment period. In addition, all subjects will be randomized 1:1 to receive either apitegromab or placebo during the treatment period.

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

Primary outcomes:
measure: Change from Baseline in total Lean Body Mass (kg) at 24 weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change from Baseline in body weight
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in percent lean body mass (%)
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in fat body mass (kg and %)
timeFrame: Baseline and 24 weeks
measure: Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)
timeFrame: Baseline and 24 weeks
measure: Percent (%) of weight loss from baseline due to fat body mass loss
timeFrame: Baseline and 24 weeks
measure: Percent (%) of weight loss from baseline due to lean body mass loss
timeFrame: Baseline and 24 weeks
measure: Concentration of apitegromab in circulation over time
timeFrame: Baseline up to 40 weeks
measure: Concentration of latent myostatin in circulation over time
timeFrame: Baseline up to 24 weeks
measure: Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Baseline up to 40 weeks
measure: Presence of anti-drug antibodies (ADA) against apitegromab over time
timeFrame: Baseline up to 40 weeks
Other outcomes:
measure: Change from Baseline in HbA1c
timeFrame: Baseline up to 32 weeks
measure: Change from baseline in fasting serum triglycerides
timeFrame: Baseline up to 32 weeks
measure: Change from baseline in total cholesterol
timeFrame: Baseline up to 32 weeks
measure: Change from baseline in low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline up to 32 weeks
Locations:
city: Chula Vista
country: United States
facility: ProSciento CRU
state: California
city: Orlando
country: United States
facility: AdventHealth Translational Research Institute
state: Florida
city: Chicago
country: United States
facility: Great Lakes Clinical Trials, LLC d/b/a Flourish Research
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Bellaire
country: United States
facility: Apex Mobile Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC dba Flourish Research
state: Texas
Study officials:
References: