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Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 1

Conditions

Type 2 Diabetes (T2D)

Treatments

Drug: Placebo
Drug: Omarigliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01088711
3102-004

Details and patient eligibility

About

This study will test the safety and tolerability of omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.

Enrollment

32 patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
  • has been diagnosed with T2D (Panel B)
  • is not actively participating in a weight loss program

Exclusion criteria

  • has a history of clinically-significant disease (other than T2D)
  • has a history of cancer
  • has estimated creatinine clearance ≤60 mL/min
  • is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • consumes excessive amounts of alcohol or caffeine
  • has participated in a previous omarigliptin study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 4 patient groups, including a placebo group

Healthy Omarigliptin
Experimental group
Description:
Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).
Treatment:
Drug: Omarigliptin
Healthy Placebo
Placebo Comparator group
Description:
Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).
Treatment:
Drug: Placebo
T2D Omarigliptin
Experimental group
Description:
Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
Treatment:
Drug: Omarigliptin
T2D Placebo
Placebo Comparator group
Description:
Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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