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

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OPKO Health

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Other: Placebo control
Drug: MOD-6031

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02692781
CP-6-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

32 participants in 5 patient groups

Dose Cohort 1
Experimental group
Description:
20mg MOD-6031 / Placebo
Treatment:
Drug: MOD-6031
Other: Placebo control
Dose Cohort 2
Experimental group
Description:
50mg MOD-6031 / Placebo
Treatment:
Drug: MOD-6031
Other: Placebo control
Dose Cohort 3
Experimental group
Description:
100mg MOD-6031 / Placebo
Treatment:
Drug: MOD-6031
Other: Placebo control
Dose Cohort 4
Experimental group
Description:
150mg MOD-6031 / Placebo
Treatment:
Drug: MOD-6031
Other: Placebo control
Dose Cohort 5
Experimental group
Description:
200mg MOD-6031 / Placebo
Treatment:
Drug: MOD-6031
Other: Placebo control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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