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.