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A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

RecruitingPhase 3

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

Conditions: Obesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus

Interventions: aleniglipron, aleniglipron, aleniglipron, Placebo

Countries: United States

This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Signed Informed Consent
* Have a BMI ≥27.0 kg/m2 at Screening
* Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

Exclusion Criteria:

* Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
* Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening.
* Have prior or planned surgical or non-surgical treatment for obesity.

Locations (74)

Birmingham, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Sun City West, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Escondido, California, United States
Fountain Valley, California, United States
Lake Forest, California, United States
Rolling Hills Estates, California, United States
San Diego, California, United States
San Diego, California, United States
Tustin, California, United States
Waterbury, Connecticut, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Columbus, Georgia, United States
Lawrenceville, Georgia, United States
Union City, Georgia, United States
Woodstock, Georgia, United States
Meridian, Idaho, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
+ 44 more on CT.gov