Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aleniglipron · 7 trials · 9 indications
Number of Participants with Clinically Significant Change from Baseline in Vital Signs: including Systolic and Diastolic Blood Pressure, Heart Rate, and temperature.
Number of Participants with Abnormal Laboratory Parameters: including hematology, serum chemistry, coagulation
Number of Participants with Clinically Significant Change from Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to: ventricular heart rate, PR interval, QRS duration, QT interval, and QTcF
Double Blind Period
Open -Label Extension
Open -Label Extension
Open -Label Extension
Open -Label Extension
Open -Label Extension
| Arm | Type | Description |
|---|---|---|
| aleniglipron Arm 1 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| aleniglipron Arm 2 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| aleniglipron Arm 3 | EXPERIMENTAL | Participants will receive aleniglipron administered orally. |
| Placebo Arm 4 | PLACEBO_COMPARATOR | Participants will receive placebo administered orally. |
| Arm 1: Participants will receive aleniglipron administered orally | EXPERIMENTAL | Drug aleniglipron administered orally |
| Arm 2: Participants will receive a placebo administered orally | EXPERIMENTAL | Drug placebo administered orally |
| Cohort 1 | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Cohort 2 | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Sentinel | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Cohort 1a | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Cohort 1b | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Cohort 1c | EXPERIMENTAL | Participants will receive aleniglipron or placebo administered orally. |
| Cohort 3 | EXPERIMENTAL | Participants will receive Aleniglipron or Placebo administered orally. |
| Cohort 1 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 2 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 3 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Cohort 4 OLE | ACTIVE_COMPARATOR | Participants will receive Aleniglipron administered orally |
| Participants will receive aleniglipron administered orally Part 1 | EXPERIMENTAL | Aleniglipron administered orally. |
| Participants will receive aleniglipron administered orally Part 2 | EXPERIMENTAL | Aleniglipron administered orally. |
| Name | Type | Description |
|---|---|---|
| aleniglipron | DRUG | Drug: aleniglipron administered orally |
| Placebo | DRUG | Drug: placebo administered orally |
| aleniglipron or placebo | DRUG | Drug: aleniglipron administered orally Drug: placebo administered orally |
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, ...
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Aleniglipron is an investigational small molecule developed by Structure Therapeutics Inc. for obesity, overweight, chronic weight management, and related metabolic conditions. It is being studied in adults with obesity or overweight, including people with type 2 diabetes and weight-related comorbidities, and in a separate study in people with hepatic impairment.
Aleniglipron targets GLP-1, the glucagon-like peptide-1 receptor. It is a small molecule designed to act on this incretin pathway, which is the same target class engaged by GLP-1 receptor agonist therapies used in weight management and diabetes care.
Aleniglipron is developed by Structure Therapeutics Inc., a company whose shares trade under the ticker GPCR. Structure Therapeutics is the sponsor of the clinical program studying aleniglipron in obesity, overweight, type 2 diabetes, and hepatic impairment.
Aleniglipron is in clinical development and is not approved for any use. Its program spans Phase 1, Phase 2, and Phase 3 studies: a completed Phase 2 trial in type 2 diabetes, two recruiting Phase 3 ACCOMPLISH trials, and a Phase 1 hepatic impairment study that has not yet begun recruiting.
Aleniglipron trials include ACCOMPLISH-1 (NCT07654361), a recruiting Phase 3 study of 3,600 participants with obesity or overweight plus a weight-related comorbidity, and ACCOMPLISH-2 (NCT07654374), a recruiting Phase 3 study of 1,100 adults with obesity or overweight and type 2 diabetes. A completed Phase 2 trial is NCT07400588, and NCT07872033 is a Phase 1 hepatic impairment study.
Aleniglipron is being studied for obesity, overweight, and chronic weight management in adults. The Phase 3 ACCOMPLISH-1 trial enrolls participants with obesity or overweight and a weight-related comorbidity, while ACCOMPLISH-2 enrolls adults with obesity or overweight who also have type 2 diabetes.