NCT07654374 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
What this study is about
This is randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study of the long-term effectiveness, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomly assigned to aleniglipron or placebo for a total of 76 weeks of treatment.
View original scientific description
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.
Interventions
DRUG
aleniglipron
Drug: aleniglipron administered orally
DRUG
aleniglipron
Drug: aleniglipron administered orally
DRUG
aleniglipron
Drug: aleniglipron administered orally
DRUG
Placebo
Drug: placebo administered orally
Primary outcome measures
Percent change in body weight from Baseline
Time frame: Baseline and week 76
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Chandler, Arizona
- Phoenix, Arizona
- Sun City West, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Escondido, California
- Fountain Valley, California
- Lake Forest, California
- Rolling Hills Estates, California
- San Diego, California
- Tustin, California
And 58 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations