Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT05762471
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
142 participants
INTERVENTIONAL
2023-01-09
2024-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Cohort 2
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Cohort 3
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Cohort 4
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Cohort 5
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
GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Interventions
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GSBR-1290
Patients will receive GSBR-1290 or matching Placebo
Placebo
Patients will receive GSBR-1290 or matching Placebo
Eligibility Criteria
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Inclusion Criteria
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
1. Men and women with T2DM of ≥6 months duration
2. Age ≥ 18 and ≤ 75 years
3. BMI ≥ 27 and ≤ 40 kg/m2
4. Treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening HbA1c ≥7.0% and ≤10.5%.
Exclusion Criteria
2. A sitting BP after resting for 5 minutes \> 160mm Hg systolic or \> 100 mm Hg diastolic or an apical pulse rate \<50 or \>100 beats per minute.
3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
4. Liver function test results elevated \> 2.0-fold above the ULN for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
5. Estimated glomerular filtration rate \< 60mL/min/1.73 m2 body surface area
6. Known hypersensitivity to any of the study drug ingredients
7. Any other condition or prior therapy that would make the participant unsuitable for this study
18 Years
75 Years
ALL
No
Sponsors
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Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
INDUSTRY
Responsible Party
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Locations
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Anaheim Clinical Trials
Anaheim, California, United States
ProSciento, Inc
Chula Vista, California, United States
QPS Miami Research Associates
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Countries
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Other Identifiers
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GSBR-1290-02
Identifier Type: -
Identifier Source: org_study_id
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