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

NCT07654361

RecruitingPhase 3

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

Conditions: Obesity, Overweight, Chronic Weight Management

Interventions: Aleniglipron, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (71)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Sun City West, Arizona, United States
  • Tucson, Arizona, United States
  • Escondido, California, United States
  • Gardena, California, United States
  • La Jolla, California, United States
  • Modesto, California, United States
  • Rolling Hills Estates, California, United States
  • San Diego, California, United States
  • Clearwater, Florida, United States
  • Leesburg, Florida, United States
  • Miami, Florida, United States
  • Ocala, Florida, United States
  • Ocoee, Florida, United States
  • Pembroke, Florida, United States
  • Tampa, Florida, United States
  • Buford, Georgia, United States
  • Columbus, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Union City, Georgia, United States
  • Woodstock, Georgia, United States
  • Honolulu, Hawaii, United States
  • Meridian, Idaho, United States
  • Rexburg, Idaho, United States
  • Chicago, Illinois, United States
  • Iowa City, Iowa, United States
  • Wichita, Kansas, United States
  • Louisville, Kentucky, United States
  • + 41 more on CT.gov