Obesity
Conditions
Keywords
Obesity
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.
Interventions
DRUGMOD-6031
OTHERPlacebo control
Sponsors
Tel-Aviv Sourasky Medical Center
OPKO Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Elimination rate constant 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 |
| CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) | 0 to 30 days |
| Vz/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 |
| T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) | 0 to 30 days |
Countries
Israel
Outcome results
None listed