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A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)

NCT01614782 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-02-05

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

MK-5823

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.

OTHER

Placebo

Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01614782 on ClinicalTrials.gov