CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 61 enrolled
Drug / intervention
MK-8521 35μg +11 moredrug
Likely dose
MK-8521 35μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02055547
NCT02055547Phase 1Completed
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A Single and Multiple-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8521 in Subjects

Merck Sharp & Dohme LLC·interventional·Posted Feb 5, 2014·Updated Jul 2, 2020

In Brief

A Phase 1 clinical trial evaluating MK-8521 35μg, MK-8521 100μg, and 10 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 61 participants.

Detailed Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8521. Part 1 primary hypothesis: Administration of single subcutaneous (SC) doses of MK-8521 is sufficiently safe and well- tolerated in healthy participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. Part 2: Administration of multiple once daily SC doses of MK-8521 is sufficiently safe and well-tolerated in healthy lean and obese participants, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2014
Enrollment StartMay 10, 2013
Primary CompletionSep 17, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.4 years ago

Interventions

MK-8521 35μgdrug

Single dose 35μg subcutaneous (SC) injection in a treatment period (Part 3, Panel H)

MK-8521 100μgdrug

Single dose 100μg SC injection in a treatment period (Part 1, Panel A) and (Part 2, Panel D)

MK-8521 125μgdrug

Single dose 125μg SC injection in a treatment period (Part 2, Panel E) and (Part 3, Panel H)

MK-8521 150μgdrug

Single dose 150μg SC injection in a treatment period (Part 1, Panel B)

MK-8521 175μgdrug

Single dose 175μg SC injection in a treatment period (Part 1, Panel B)

MK-8521 200μgdrug

Single dose MK-8521 200μg SC injection in a treatment period (Part 1, Panel B)

MK-8521 300μgdrug

Single dose 300μg SC injection in a treatment period (Part 1, Panel A)

MK-8521 50/72μgdrug

MK-8521 50μg SC injection Days 1-5 and 72μg Days 6-10 (Part 2, Panel C)

MK-8521 72/125μgdrug

MK-8521 72μg SC injection Days 1-7 and 125μg Days 8-14 (Part 2, Panel F)

MK-8521 100/150μgdrug

MK-8521 100μg SC injection Days 1-5 and 150μg Days 6-10 SC in a treatment period (Part 2, Panel D)

MK-8521 125/150μgdrug

MK-8521 SC 125μg SC injection Days 1-5 and 150μg Days 6-10 (Part 2, Panel E)

Placebodrug

Placebo to MK-8521 SC injection in a treatment period (Parts 1, 2, and 3)