Overview

A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects

Status:
Completed
Trial end date:
2016-12-15
Target enrollment:
0
Participant gender:
Male
Summary
MOD-6031 is a long-acting reversibly PEGylated oxyntomodulin (OXM) therapeutic. The active moiety is a gastrointestinal neuropeptide with a sequence identical to endogenous human OXM and is an agonist for both glucagon-like peptide-1 (GLP1) and glucagon (GCG) receptors. The peptide is a natural appetite suppressant, secreted by L-cells in the digestive system following food intake leading to a decrease in gastric emptying, satiety after crossing the blood-brain barrier, and regulation of insulin and glucose levels. Thus, MOD-6031 is being developed as a treatment for high risk subjects (obese) to increase weight loss, reduce food intake and increase glycemic control.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Opko Biologics
OPKO Health, Inc.
Collaborator:
Tel-Aviv Sourasky Medical Center
Criteria
Inclusion Criteria:

- Healthy male, between 18 to 55 years of age.

- BMI 27-35 Kg/m2 (inclusive).

- Generally good health.

- Triglyceride ≤ 400mg/ml

- ECG with no clinically significant abnormalities.

- Negative HIV, hepatitis B or hepatitis C serology tests at screening

- No significant abnormalities in clinical laboratory parameters

- No history of alcohol or drug abuse.

Exclusion Criteria:

- History of clinically significant medical condition.

- Any cardiac conduction defect.

- Any acute or unstable disease.

- History of malignancy diagnosed within the past 5 years.

- Known or suspected diabetes and/or HbA1C >6.4% on screening.

- Known allergy to any drug.

- Treatment with weight loss drugs (within 3 months prior to dosing).

- Liposuction or other surgery for weight loss within the last year.

- Evidence of eating disorders (bulimia, binge eating).

- History of regular alcohol consumption exceeding.

- Use of tobacco or nicotine-containing products.

- Subjects that have difficulty fasting or consuming the standard meals that will be
provided.