Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1) (NCT07654361)
A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity
🩺 Plain-English Summary (8th-Grade Level)
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.
Who can join: Review the eligibility criteria below.
Location: ACCOMPLISH-1 Research Site — Birmingham, Alabama
Age range: 18 Years to 79 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (71 Sites)
Showing the first 25 of 71 sites.
- ACCOMPLISH-1 Research Site — Birmingham, Alabama
- ACCOMPLISH-1 Research Site — Birmingham, Alabama
- ACCOMPLISH-1 Research Site — Phoenix, Arizona
- ACCOMPLISH-1 Research Site — Sun City West, Arizona
- ACCOMPLISH-1 Research Site — Tucson, Arizona
- ACCOMPLISH-1 Research Site — Escondido, California
- ACCOMPLISH-1 Research Site — Gardena, California
- ACCOMPLISH-1 Research Site — La Jolla, California
- ACCOMPLISH-1 Research Site — Modesto, California
- ACCOMPLISH-1 Research Site — Rolling Hills Estates, California
- ACCOMPLISH-1 Research Site — San Diego, California
- ACCOMPLISH-1 Research Site — Clearwater, Florida
- ACCOMPLISH-1 Research Site — Leesburg, Florida
- ACCOMPLISH-1 Research Site — Miami, Florida
- ACCOMPLISH-1 Research Site — Ocala, Florida
- ACCOMPLISH-1 Research Site — Ocoee, Florida
- ACCOMPLISH-1 Research Site — Pembroke, Florida
- ACCOMPLISH-1 Research Site — Tampa, Florida
- ACCOMPLISH-1 Research Site — Buford, Georgia
- ACCOMPLISH-1 Research Site — Columbus, Georgia
- ACCOMPLISH-1 Research Site — Lawrenceville, Georgia
- ACCOMPLISH-1 Research Site — Union City, Georgia
- ACCOMPLISH-1 Research Site — Woodstock, Georgia
- ACCOMPLISH-1 Research Site — Honolulu, Hawaii
- ACCOMPLISH-1 Research Site — Meridian, Idaho
📞 Contact the Study Coordinator
Phone: (650) 457-1959
Email: GSBRClinicalTrials@structuretx.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.