A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects
- Registration Number
- NCT02692781
- Lead Sponsor
- OPKO Health, Inc.
- Brief 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.
- Detailed Description
This will be a a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study. Five escalating dose groups are planned, with 8 subjects per dose group, randomized in 3:1 ratio to receive a single dose of MOD-6031 or matching Placebo (6 MOD-6031 to 2 placebo subjects). The initial MOD-6031 dose will be 20 mg, followed by single doses of 50 mg, 100 mg, 150 mg and 200 mg. Each subject will receive a single study drug injection in the morning (dosing day designated as Day 0) and will be monitored for 30 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Cohort 3 Placebo control 100mg MOD-6031 / Placebo Dose Cohort 5 Placebo control 200mg MOD-6031 / Placebo Dose Cohort 4 Placebo control 150mg MOD-6031 / Placebo Dose Cohort 1 Placebo control 20mg MOD-6031 / Placebo Dose Cohort 2 Placebo control 50mg MOD-6031 / Placebo Dose Cohort 4 MOD-6031 150mg MOD-6031 / Placebo Dose Cohort 5 MOD-6031 200mg MOD-6031 / Placebo Dose Cohort 1 MOD-6031 20mg MOD-6031 / Placebo Dose Cohort 2 MOD-6031 50mg MOD-6031 / Placebo Dose Cohort 3 MOD-6031 100mg MOD-6031 / Placebo
- Primary Outcome Measures
Name Time Method Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions 30 days
- Secondary Outcome Measures
Name Time Method Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) 0 to 30 days
Trial Locations
- Locations (1)
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel