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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-15

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

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MOD-6031

Intervention Type DRUG

Placebo control

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes