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HomeTrials › NCT07654361

Obesity & weight · Phase 3 · Recruiting now

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 recruiting now 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 · Opening soon
  • ACCOMPLISH-1 Research Site, Birmingham · Opening soon

Arizona

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

California

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

Florida

  • ACCOMPLISH-1 Research Site, Clearwater · Recruiting now
  • ACCOMPLISH-1 Research Site, Leesburg · Opening soon
  • ACCOMPLISH-1 Research Site, Miami · Opening soon
  • ACCOMPLISH-1 Research Site, Ocala · Opening soon
  • ACCOMPLISH-1 Research Site, Ocoee · Opening soon
  • ACCOMPLISH-1 Research Site, Pembroke · Opening soon
  • ACCOMPLISH-1 Research Site, Tampa · Opening soon

Georgia

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

Hawaii

  • ACCOMPLISH-1 Research Site, Honolulu · Recruiting now

Idaho

  • ACCOMPLISH-1 Research Site, Meridian · Opening soon
  • ACCOMPLISH-1 Research Site, Rexburg · Opening soon

Illinois

  • ACCOMPLISH-1 Research Site, Chicago · Opening soon

Iowa

  • ACCOMPLISH-1 Research Site, Iowa City · Opening soon

Kansas

  • ACCOMPLISH-1 Research Site, Wichita · Opening soon

Kentucky

  • ACCOMPLISH-1 Research Site, Louisville · Opening soon

Louisiana

  • ACCOMPLISH-1 Research Site, Baton Rouge · Opening soon

Maryland

  • ACCOMPLISH-1 Research Site, Silver Spring · Recruiting now

Massachusetts

  • ACCOMPLISH-1 Research Site, Methuen · Opening soon
  • ACCOMPLISH-1 Research Site, Needham · Opening soon

Michigan

  • ACCOMPLISH-1 Research Site, Ann Arbor · Opening soon

Minnesota

  • ACCOMPLISH-1 Research Site, Mankato · Recruiting now
  • ACCOMPLISH-1 Research Site, Richfield · Recruiting now

Mississippi

  • ACCOMPLISH-1 Research Site, Gulfport · Opening soon
  • ACCOMPLISH-1 Research Site, Ridgeland · Opening soon

Missouri

  • ACCOMPLISH-1 Research Site, Chesterfield · Opening soon
  • ACCOMPLISH-1 Research Site, Hazelwood · Recruiting now
  • ACCOMPLISH-1 Research Site, St Louis · Recruiting now

Montana

  • ACCOMPLISH-1 Research Site, Butte · Opening soon
  • ACCOMPLISH-1 Research Site, Missoula · Opening soon

Nebraska

  • ACCOMPLISH-1 Research Site, Omaha · Opening soon

Nevada

  • ACCOMPLISH-1 Research Site, Las Vegas · Opening soon

New York

  • ACCOMPLISH-1 Research Site, Albany · Opening soon
  • ACCOMPLISH-1 Research Site, Brooklyn · Opening soon

North Carolina

  • ACCOMPLISH-1 Research Site, Charlotte · Recruiting now
  • ACCOMPLISH-1 Research Site, Durham · Opening soon
  • ACCOMPLISH-1 Research Site, Fayetteville · Opening soon
  • ACCOMPLISH-1 Research Site, New Bern · Opening soon
  • ACCOMPLISH-1 Research Site, Wilmington · Recruiting now
  • ACCOMPLISH-1 Research Site, Winston-Salem · Opening soon

Ohio

  • ACCOMPLISH-1 Research Site, Columbus · Opening soon
  • ACCOMPLISH-1 Research Site, Columbus · Recruiting now

Oklahoma

  • ACCOMPLISH-1 Research Site, Moore · Opening soon

Oregon

  • ACCOMPLISH-1 Research Site, Portland · Recruiting now

Pennsylvania

  • ACCOMPLISH-1 Research Site, Philadelphia · Opening soon

South Carolina

  • ACCOMPLISH-1 Research Site, Greer · Opening soon

Tennessee

  • ACCOMPLISH-1 Research Site, Knoxville · Opening soon

Texas

  • ACCOMPLISH-1 Research Site, Austin · Opening soon
  • ACCOMPLISH-1 Research Site, Austin · Recruiting now
  • ACCOMPLISH-1 Research Site, Denison · Opening soon
  • ACCOMPLISH-1 Research Site, Houston · Opening soon
  • ACCOMPLISH-1 Research Site, Houston · Opening soon
  • ACCOMPLISH-1 Research Site, San Antonio · Opening soon
  • ACCOMPLISH-1 Research Site, Wylie · Opening soon

Utah

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

Washington

  • ACCOMPLISH-1 Research Site, Renton · Recruiting now

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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