A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM (NCT07667803)
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)
🩺 Plain-English Summary (8th-Grade Level)
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (9 items).
Location: Research Site — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria
- Study 1 - Established diagnosis of T1DM or T2DM.
- Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- T1DM
- HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.
- Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
- History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (321 Sites)
Showing the first 25 of 321 sites.
- Research Site — Birmingham, Alabama
- Research Site — Dothan, Alabama
- Research Site — Chandler, Arizona
- Research Site — Peoria, Arizona
- Research Site — Little Rock, Arkansas
- Research Site — Lynwood, California
- Research Site — Rolling Hills Estates, California
- Research Site — Sacramento, California
- Research Site — Arvada, Colorado
- Research Site — New Haven, Connecticut
- Research Site — Clearwater, Florida
- Research Site — Plantation, Florida
- Research Site — Woodstock, Georgia
- Research Site — Ammon, Idaho
- Research Site — Melrose Park, Illinois
- Research Site — Indianapolis, Indiana
- Research Site — Wichita, Kansas
- Research Site — Louisville, Kentucky
- Research Site — Alexandria, Louisiana
- Research Site — Baltimore, Maryland
- Research Site — Potomac, Maryland
- Research Site — White Marsh, Maryland
- Research Site — Ypsilanti, Michigan
- Research Site — Ridgeland, Mississippi
- Research Site — Kansas City, Missouri
📞 Contact the Study Coordinator
Phone: (877) 240-9479
Email: information.center@astrazeneca.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.