NCT02692781

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

A Phase I, Randomized, Single-Blinded, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of MOD-6031 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	MOD-6031
OTHER	Placebo control

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-15
• Completion: 2016-12-15
• First posted: 2016-02-26
• Last updated: 2019-09-30

Locations

1 site across 1 country: Israel