Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05762471 | Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 142 | — | — | Jan 9, 2023 | Apr 11, 2024 | Apr 25, 2024 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 2 | EXPERIMENTAL | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 3 | EXPERIMENTAL | Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks |
| Cohort 4 | EXPERIMENTAL | HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks |
| Cohort 5 | EXPERIMENTAL | Participants with T2DM(Cohort 5) will be randomized to placebo, low-dose, or high-dose arms. Participants in the low-dose, high-dose or placebo arms will receive multiple-ascending doses for 12 weeks |
| Name | Type | Description |
|---|---|---|
| GSBR-1290 | DRUG | Patients will receive GSBR-1290 or matching Placebo |
| Placebo | DRUG | Patients will receive GSBR-1290 or matching Placebo |
Inclusion Criteria cohorts 1-4: 1. Provided evidence of a signed consent 2. Age ≥ 18 and ≤ 75 years 3. Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 4. No nicotine use 5. Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: 1. Men a...