Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus
Overweight or Obesity, Type2 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Overweight or Obesity
Eligibility Criteria
Inclusion Criteria cohorts 1-4: Provided evidence of a signed consent Age ≥ 18 and ≤ 75 years Healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 No nicotine use Have a suitable venous access for blood sampling Inclusion Criteria cohort 5: Men and women with T2DM of ≥6 months duration Age ≥ 18 and ≤ 75 years BMI ≥ 27 and ≤ 40 kg/m2 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: History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months 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. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval 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 Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area Known hypersensitivity to any of the study drug ingredients Any other condition or prior therapy that would make the participant unsuitable for this study
Sites / Locations
- Anaheim Clinical Trials
- ProSciento, Inc
- QPS Miami Research Associates
- Progressive Medical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
Patients will receive once daily doses of study drug (GSBR-1290 or Placebo) for a total of 4 weeks
HOV participants (Cohort 4) will receive multiple-ascending doses of GSBR-1290 or placebo for a total of 12 weeks
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