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

NCT07654374 · tracked via the Priya Life Science USA tracker

Sponsor

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

Phase

Phase 3

Started

2026-07-17

Last updated

2026-09-11

Condition(s) studied

ObesityOverweightChronic Weight ManagementType2 Diabetes Mellitus

Investigational drug(s) / intervention(s)

aleniglipron →aleniglipron →aleniglipron →Placebo

aleniglipron: Drug: aleniglipron administered orally

Placebo: Drug: placebo administered orally

Study summary

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

Sex

ALL

Min age

18 Years

Max age

79 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Percent change in body weight from Baseline — Baseline and week 76

Trial sites (74)

Facility	City	Region	Status
ACCOMPLISH-2 Research Site	Birmingham	Alabama	Recruiting
ACCOMPLISH-2 Research Site	Chandler	Arizona	Recruiting
ACCOMPLISH-2 Research Site	Phoenix	Arizona	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Sun City West	Arizona	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Tucson	Arizona	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Little Rock	Arkansas	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Escondido	California	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Fountain Valley	California	Recruiting
ACCOMPLISH-2 Research Site	La Jolla	California	Recruiting
ACCOMPLISH-2 Research Site	Lake Forest	California	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Rolling Hills Estates	California	Recruiting
ACCOMPLISH-2 Research Site	San Diego	California	Recruiting
ACCOMPLISH-2 Research Site	Tustin	California	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Waterbury	Connecticut	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Clearwater	Florida	Recruiting
ACCOMPLISH-2 Research Site	Fort Myers	Florida	Recruiting
ACCOMPLISH-2 Research Site	Jacksonville	Florida	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Leesburg	Florida	Recruiting
ACCOMPLISH-2 Research Site	Miami	Florida	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Ocala	Florida	Recruiting
ACCOMPLISH-2 Research Site	Ocoee	Florida	Recruiting
ACCOMPLISH-2 Research Site	Pembroke Pines	Florida	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Atlanta	Georgia	Recruiting
ACCOMPLISH-2 Research Site	Columbus	Georgia	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Lawrenceville	Georgia	Recruiting
ACCOMPLISH-2 Research Site	Union City	Georgia	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Woodstock	Georgia	Recruiting
ACCOMPLISH-2 Research Site	Meridian	Idaho	Recruiting
ACCOMPLISH-2 Research Site	Des Moines	Iowa	Recruiting
ACCOMPLISH-2 Research Site	Iowa City	Iowa	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Wichita	Kansas	Recruiting
ACCOMPLISH-2 Research Site	Silver Spring	Maryland	Recruiting
ACCOMPLISH-2 Research Site	Methuen	Massachusetts	Recruiting
ACCOMPLISH-2 Research Site	Mankato	Minnesota	Recruiting
ACCOMPLISH-2 Research Site	Minneapolis	Minnesota	Recruiting
ACCOMPLISH-2 Research Site	Gulfport	Mississippi	Recruiting
ACCOMPLISH-2 Research Site	Ridgeland	Mississippi	Not Yet Recruiting
ACCOMPLISH-2 Research Site	Chesterfield	Missouri	Not Yet Recruiting
ACCOMPLISH-2 Research Site	City of Saint Peters	Missouri	Recruiting
ACCOMPLISH-2 Research Site	Hazelwood	Missouri	Recruiting

+ 34 more sites — see the full list on the official registry below.

More Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics trials in the USA

Aleniglipron Phase 2 in Type 2 Diabetes Mellitus Active, not recruiting

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

Aleniglipron Phase 2 Body Composition Study Active, not recruiting

Other trials for the same condition

A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity Active, not recruiting

A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight Active, not recruiting

A Research Study on How Well Different Doses of the Medicine UBT251 Help People Living With Overweight or Obesity Recruiting

A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy Enrolling by invitation

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07654374 on ClinicalTrials.gov ↗ ← All trials in the USA