Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: yes

Brief summary:
This 3-part study will explore the safety and tolerability of GLWL-01 in overweight/obese healthy participants after single doses (in Part A), and in participants with type 2 diabetes mellitus after multiple doses during a 28-day period (Parts B and C).

Detailed description:

Arms:
arm 1: Escalating dose in at least 2 of 3 periods, starting at 10 milligrams (mg) arm 2: Escalating dose of placebo to match GLWL-01, in 1 period arm 3: Multiple ascending daily doses of GLWL-01 at up to six dose levels, based on Part A arm 4: Multiple daily doses of placebo to match GLWL-01 arm 5: Multiple daily doses of GLWL-01 at level based upon Part B arm 6: Multiple daily doses of placebo to match GLWL-01

Interventions: intervention 1: GLWL-01, Part A intervention 2: Placebo, Part A intervention 3: GLWL-01, Part B intervention 4: Placebo, Part B intervention 5: GLWL-01, Part C intervention 6: Placebo, Part C
Intervention descriptions: intervention 1: Capsules administered orally, in 2 out of 3 periods intervention 2: Capsules administered orally in 1 out of 3 periods intervention 3: Capsules administered orally either once or twice daily for 27 days, with a single dose on Day 28 intervention 4: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28 intervention 5: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28 intervention 6: Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28

Protocol document: