| Trial ID: | L6838 |
| Source ID: | NCT05762471
|
| Associated Drug: |
Gsbr-1290
|
| Title: |
Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Overweight or Obesity|Type2 Diabetes Mellitus
|
| Interventions: |
DRUG: GSBR-1290|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV and T2DM, 42 days | Secondary: Analysis of Cmax at specified timepoints predose and postdose to calculate PK parameters, 31 days|Analysis of Tmax at specified timepoints predose and postdose to calculate PK parameters, 31 days|Analysis of AUC at specified timepoints predose and postdose to calculate PK parameters, 31 days|Identification of GSBR-1290 metabolites following oral administration of multiple doses in plasma, 31 days
|
| Sponsor/Collaborators: |
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
142
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-01-09
|
| Completion Date: |
2024-04-11
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-25
|
| Locations: |
Anaheim Clinical Trials, Anaheim, California, 92801, United States|ProSciento, Inc, Chula Vista, California, 91911, United States|QPS Miami Research Associates, Miami, Florida, 33143, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05762471
|
