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

Launched by SCHOLAR ROCK, INC. · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness and safety of a new treatment called apitegromab for adults who are overweight or obese. The study aims to see how well apitegromab works when used alongside another type of medication known as GLP-1 agonists, which are often prescribed to help with weight loss. The trial is currently active but not recruiting new participants, meaning they are not looking for more volunteers at this time.

To be eligible for this trial, participants need to be between 18 and 65 years old and have a stable body weight within 5 kilograms for at least the last three months. They also need to have a Body Mass Index (BMI) that falls within certain ranges, indicating overweight or obesity. However, people with certain health conditions, like severe heart problems or active cancer, cannot participate. If someone joins the trial, they can expect to undergo various assessments related to their health and treatment response throughout the study period. Overall, this trial is important as it may help improve weight management strategies for adults facing obesity.

Gender

ALL

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