Conditions: Obesity
Keywords: metformin diabetes obesity liraglutide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: yes

Brief summary:
This study is the first administration of GSK2890457 in humans. The study will be conducted in 3 parts: - Part A (conducted at a single investigative site) will determine the safety and tolerability of GSK2890457 alone in healthy subjects during six weeks of dosing, as well as evaluating the potential for a pharmacokinetic interaction with metformin. Part A consists of Screening, Treatment (6 weeks) and Follow-up periods. - Part B (conducted at multiple sites) will determine safety, tolerability, and pharmacodynamics (PD) in subjects with Type 2 diabetes (T2D) when co-dosed for six weeks with liraglutide (Victoza). Part B consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods. - Part C (conducted at multiple sites) will determine safety, tolerability, and PD in subjects with T2D when co-dosed for 6 weeks with metformin. Part C consists of Screening, Run-in (1 week), Stabilization (12 weeks), Treatment (6 weeks) and Follow-up periods.

Detailed description:

Arms:
arm 1: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 2: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 3: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 4: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 5: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks arm 6: Subjects will titrate up from a maximially tolerated dose over a 7-day period. Treatment Period is 6 weeks

Interventions: intervention 1: GSK2890457 intervention 2: Metformin intervention 3: Placebo intervention 4: Liraglutide
Intervention descriptions: intervention 1: Provided as powder and capsule. intervention 2: Tablet

Part A: Single doses on Day 1 and Day 42 orally

Part B: Subject continues usual metformin dose through Run-in, and resumes after Treatment Period completed

Part C: Subject continues usual metformin dose throughout study intervention 3: Provided as powder and Capsule. intervention 4: Provided as Injection. 6mg/mL, 3mL injector pen that permits doses of 0.6mg, 1.2mg, and 1.8mg

Subcutaneous injection 18 weeks dosing (Stabilization and Treatment Periods, Part B only

Protocol document: