Phase 1b/2a Study of GSBR-1290 in Adult Overweight or Obese Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Korábbi kezelés

• Any other condition or prior therapy that would make the participant unsuitable for this study

Más betegség

• 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
• Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
• Known hypersensitivity to any of the study drug ingredients

Laborértékek

• 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

Egyéb

• 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.
• Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area

• 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
• 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%.