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HomeTrials › NCT07654361

Obesity & weight · Phase 3 · Opening soon

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

NCT07654361 · Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

What this trial means for you

This study is opening soon at 71 US sites. It's studying Aleniglipron, Placebo for obesity, overweight, chronic weight management.

Who can joinAll sexes, 18 Years – 79 Years
Healthy volunteersNo, diagnosis required
What you'd takeAleniglipron, Placebo
Study length~2.2 years overall
Planned participants3,600
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes. * Self-reported change in body weight \>5 kg within 3 months before Screening. * Have prior or planned surgical or non-surgical treatment for obesity. * Have or plan to have endoscopic and/or device-based therapy for obesity. * Have obesity induced by other endocrine disorders. * Impaired renal function at Screening * Chronic malabsorption

Study sites by state

Alabama

  • ACCOMPLISH-1 Research Site, Birmingham
  • ACCOMPLISH-1 Research Site, Birmingham

Arizona

  • ACCOMPLISH-1 Research Site, Phoenix
  • ACCOMPLISH-1 Research Site, Sun City West
  • ACCOMPLISH-1 Research Site, Tucson

California

  • ACCOMPLISH-1 Research Site, Escondido
  • ACCOMPLISH-1 Research Site, Gardena
  • ACCOMPLISH-1 Research Site, La Jolla
  • ACCOMPLISH-1 Research Site, Modesto
  • ACCOMPLISH-1 Research Site, Rolling Hills Estates
  • ACCOMPLISH-1 Research Site, San Diego

Florida

  • ACCOMPLISH-1 Research Site, Clearwater
  • ACCOMPLISH-1 Research Site, Leesburg
  • ACCOMPLISH-1 Research Site, Miami
  • ACCOMPLISH-1 Research Site, Ocala
  • ACCOMPLISH-1 Research Site, Ocoee
  • ACCOMPLISH-1 Research Site, Pembroke
  • ACCOMPLISH-1 Research Site, Tampa

Georgia

  • ACCOMPLISH-1 Research Site, Buford
  • ACCOMPLISH-1 Research Site, Columbus
  • ACCOMPLISH-1 Research Site, Lawrenceville
  • ACCOMPLISH-1 Research Site, Union City
  • ACCOMPLISH-1 Research Site, Woodstock

Hawaii

  • ACCOMPLISH-1 Research Site, Honolulu

Idaho

  • ACCOMPLISH-1 Research Site, Meridian
  • ACCOMPLISH-1 Research Site, Rexburg

Illinois

  • ACCOMPLISH-1 Research Site, Chicago

Iowa

  • ACCOMPLISH-1 Research Site, Iowa City

Kansas

  • ACCOMPLISH-1 Research Site, Wichita

Kentucky

  • ACCOMPLISH-1 Research Site, Louisville

Louisiana

  • ACCOMPLISH-1 Research Site, Baton Rouge

Maryland

  • ACCOMPLISH-1 Research Site, Silver Spring

Massachusetts

  • ACCOMPLISH-1 Research Site, Methuen
  • ACCOMPLISH-1 Research Site, Needham

Michigan

  • ACCOMPLISH-1 Research Site, Ann Arbor

Minnesota

  • ACCOMPLISH-1 Research Site, Mankato
  • ACCOMPLISH-1 Research Site, Richfield

Mississippi

  • ACCOMPLISH-1 Research Site, Gulfport
  • ACCOMPLISH-1 Research Site, Ridgeland

Missouri

  • ACCOMPLISH-1 Research Site, Chesterfield
  • ACCOMPLISH-1 Research Site, Hazelwood
  • ACCOMPLISH-1 Research Site, St Louis

Montana

  • ACCOMPLISH-1 Research Site, Butte
  • ACCOMPLISH-1 Research Site, Missoula

Nebraska

  • ACCOMPLISH-1 Research Site, Omaha

Nevada

  • ACCOMPLISH-1 Research Site, Las Vegas

New York

  • ACCOMPLISH-1 Research Site, Albany
  • ACCOMPLISH-1 Research Site, Brooklyn

North Carolina

  • ACCOMPLISH-1 Research Site, Charlotte
  • ACCOMPLISH-1 Research Site, Durham
  • ACCOMPLISH-1 Research Site, Fayetteville
  • ACCOMPLISH-1 Research Site, New Bern
  • ACCOMPLISH-1 Research Site, Wilmington
  • ACCOMPLISH-1 Research Site, Winston-Salem

Ohio

  • ACCOMPLISH-1 Research Site, Columbus
  • ACCOMPLISH-1 Research Site, Columbus

Oklahoma

  • ACCOMPLISH-1 Research Site, Moore

Oregon

  • ACCOMPLISH-1 Research Site, Portland

Pennsylvania

  • ACCOMPLISH-1 Research Site, Philadelphia

South Carolina

  • ACCOMPLISH-1 Research Site, Greer

Tennessee

  • ACCOMPLISH-1 Research Site, Knoxville

Texas

  • ACCOMPLISH-1 Research Site, Austin
  • ACCOMPLISH-1 Research Site, Austin
  • ACCOMPLISH-1 Research Site, Denison
  • ACCOMPLISH-1 Research Site, Houston
  • ACCOMPLISH-1 Research Site, Houston
  • ACCOMPLISH-1 Research Site, San Antonio
  • ACCOMPLISH-1 Research Site, Wylie

Utah

  • ACCOMPLISH-1 Research Site, Sandy City
  • ACCOMPLISH-1 Research Site, St. George

Washington

  • ACCOMPLISH-1 Research Site, Renton

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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