Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese (EMBRAZE)

Scholar Rock

Status and phase: Active, not recruiting; Phase 2

Conditions: Overweight and Obesity

Treatments: Drug: Apitegromab; Drug: Placebo; Drug: Semaglutide; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06445075

SRK-015-006

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Apitegromab + incretin mimetic

Treatment:

Drug: Tirzepatide

Drug: Semaglutide

Drug: Apitegromab

Cohort 2

Placebo Comparator group

Description:

Placebo + incretin mimetic

Treatment:

Drug: Tirzepatide

Drug: Semaglutide

Drug: Placebo