The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level. In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.
Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
Number of participants who experienced at least one adverse event
Time frame: Up to 49 days
Number of participants who discontinued from study drug due to an adverse event
Time frame: Up to 21 days
Area under the plasma concentration time curve from Hour 0 to Hour 24 (AUC0-24) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Maximum plasma concentration (Cmax) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Lowest plasma concentration (Ctrough) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Time to maximum plasma concentration (Tmax) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
Apparent terminal half-life (apparent t1/2) following once daily administration of MK-5823
Time frame: Predose on Day 1 (baseline) through 672 hours following the initial dose
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