Recent research has revealed promising insights regarding the effects of apitegromab on preserving lean mass during weight loss induced by tirzepatide. A phase 2 trial, known as EMBRAZE, evaluated this interaction among adults within a controlled setting.
Study Overview
The EMBRAZE trial was a randomized, double-blind, placebo-controlled study registered under NCT06445075. Conducted across seven sites in the United States, it aimed to assess the efficacy and safety of apitegromab combined with tirzepatide.
Trial Approval and Compliance
The trial received approval from Advarra, an institutional review board (IRB), as well as from several local IRBs. It adhered to the Declaration of Helsinki and Good Clinical Practice guidelines.
- ProSciento CRU, Chula Vista, California
- AdventHealth Translational Research Institute, Orlando, Florida
- Great Lakes Clinical Trials, LLC, Chicago, Illinois
- Tandem Clinical Research GI, LLC, Marrero, Louisiana
- Alliance for Multispecialty Research, LLC, Norman, Oklahoma
- Apex Mobile Clinical Research, Bellaire, Texas
- Clinical Trials of Texas, LLC, San Antonio, Texas
Participant Criteria
Eligible participants included adults aged 18 to 65 years with a BMI of 27 or higher, or a BMI between 30 and 45 kg/m². All candidates needed a stable body weight within five kilograms over the past 90 days and a history of unsuccessful weight loss efforts.
Exclusion Factors
Individuals with a history of various health issues were excluded, including:
- Cardiovascular diseases
- Active malignancies
- Type 1 or Type 2 diabetes
- Pulmonary diseases
Patients on specific medications or with a history of certain disorders also faced exclusion from the trial.
Trial Procedures
Baseline characteristics were meticulously documented through standard assessments, including complete physical examinations. Following informed consent, participants received either apitegromab plus tirzepatide or placebo combined with tirzepatide over a 24-week period.
The primary endpoint focused on changes in lean body mass measured by DEXA scans after 24 weeks. Secondary endpoints evaluated weight, total fat mass, and additional body composition metrics.
Study Timeline
- 4-week screening period
- Initial dosing on day 1
- Treatment duration: 24 weeks
- Safety monitoring period: 16 weeks
Results Assessment
Data analysis employed a range of statistical methods. The primary population consisted of participants who completed treatment and had valid DEXA data. The trial planned to enroll approximately 50 participants per study arm, anticipating some would not be evaluable for the primary analysis.
Conclusion
The EMBRAZE study offers significant insights into apitegromab’s role in maintaining lean mass during weight loss linked to tirzepatide. Further research will enhance understanding of this promising treatment combination.
