NCT07654374RecruitingPhase 3
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1100 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- 17 Jul 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07654374
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1100
- From 17 Jul 2026 to the primary completion date, 30 Sept 2028
- 70 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
Who the study is looking for
- 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
Age in the registry: 18 years to 79 years · Sex: All · Accepts healthy volunteers
Sites (70)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Albany | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Brooklyn | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Burke | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Chesterfield | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Des Moines | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Escondido | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Farmers Branch | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Fayetteville | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Fountain Valley | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Greer | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Gulfport | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Hazelwood | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Iowa City | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Lake Forest | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Las Vegas | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Lawrenceville | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Leesburg | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Little Rock | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Manassas | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Mankato | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Methuen | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Miami | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Missoula | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Moore | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Morehead City | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Ocala | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Ocoee | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Omaha | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Pembroke Pines | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Renton | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Ridgeland | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Rolling Hills Estates | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Salt Lake City | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Silver Spring | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Suffolk | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Sun City West | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Tustin | United States | Not yet recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Union City | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Waterbury | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Wichita | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Woodstock | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Wylie | United States | Recruiting |
| ACCOMPLISH-2 Research Site Coordinator of this site? Confirm its status | Yukon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.