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)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK-5823; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614782

5823-002

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential
• A Body Mass Index between 27 and 35 kg/m^2 and weighs at least 50 kg
• Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM
• For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin
• A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion criteria

• History of stroke, chronic seizures or major neurological disorder
• History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
• History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)
• Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.
• History of neoplastic disease
• History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness
• Requires treatment with systemic or ocular corticosteroids
• For T2DM Panels, a history of hypoglycemic unawareness
• For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin
• For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation
• Unable to refrain from using any medication beginning 2 weeks before study participation
• Consumes excessive amounts of alcohol (>3 per day)
• Consumes more than 6 caffeinated beverages per day
• Had major surgery or donated or lost more than 1 unit of blood
• Participated in another investigational study within 4 weeks of study participation
• History of significant multiple and/or severe allergies or anaphylactic reaction
• Hypersensitivity to glucagon or insulin
• Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation
• Woman of child-bearing potential or is a nursing mother
• For T2DM Panels, age >50 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 6 patient groups

0.35 mg MK-5823 - Healthy Participants

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823

0.7 mg MK-5823 - Healthy Participants

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823

1.4 mg MK-5823 - Healthy Participants

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823

2.8 mg MK-5823 - Healthy Participants

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823

1.4 mg MK-5823 - Participants with T2DM

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823

2.8 mg MK-5823 - Participants with T2DM

Experimental group

Treatment:

Other: Placebo

Drug: MK-5823