Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aleniglipron · 4 trials · 8 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 Clinically Significant Change from Baseline in 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. |
| 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 |
| 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 being developed for chronic weight management in adults with obesity or overweight, including those with weight-related comorbidities such as type 2 diabetes mellitus. It is being studied in clinical trials for conditions including obesity, overweight, and chronic weight management.
Aleniglipron targets the GLP-1 receptor. As a small molecule GLP-1 agonist, it is designed to activate the glucagon-like peptide-1 pathway, which plays a role in glucose metabolism and appetite regulation. This mechanism is being investigated for its potential in weight management and metabolic conditions.
Aleniglipron is being developed by Structure Therapeutics Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol GPCR. The company is conducting clinical trials to evaluate the drug's efficacy and safety in adults with obesity or overweight and related metabolic conditions.
Aleniglipron is in Phase 2 clinical development. While some trials listed under its name are Phase 3, the drug's overall development stage is Phase 2, as it is still being evaluated for efficacy and safety in clinical studies. It is investigational and not yet approved by regulatory authorities.
Aleniglipron is being studied in several clinical trials, including NCT07654374 (ACCOMPLISH-2) in adults with obesity or overweight and type 2 diabetes, NCT07654361 (ACCOMPLISH-1) in obesity or overweight with weight-related comorbidity, NCT07400588 in type 2 diabetes, and NCT06693843, a Phase 2b dose-ranging study in obesity or overweight.
Yes, Aleniglipron is also known as GSBR-1290. The Phase 2b clinical trial NCT06693843 explicitly refers to Aleniglipron (GSBR-1290) in its title, confirming that these names refer to the same investigational drug being developed by Structure Therapeutics Inc.