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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692781
• Other study ID #: CP-6-001
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: December 15, 2016

Study information

• Verified date: September 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• MOD-6031

Other:
• Placebo control

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
OPKO Health, Inc.	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions		30 days
Secondary	Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days
Secondary	Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)		0 to 30 days