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

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ClinicalTrials.gov Identifier: NCT02692781
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
OPKO Health, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: MOD-6031 Other: Placebo control Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Arm Intervention/treatment
Experimental: Dose Cohort 1
20mg MOD-6031 / Placebo
Drug: MOD-6031
Other: Placebo control
Experimental: Dose Cohort 2
50mg MOD-6031 / Placebo
Drug: MOD-6031
Other: Placebo control
Experimental: Dose Cohort 3
100mg MOD-6031 / Placebo
Drug: MOD-6031
Other: Placebo control
Experimental: Dose Cohort 4
150mg MOD-6031 / Placebo
Drug: MOD-6031
Other: Placebo control
Experimental: Dose Cohort 5
200mg MOD-6031 / Placebo
Drug: MOD-6031
Other: Placebo control



Primary Outcome Measures :
  1. Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  2. Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  3. AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  4. AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  5. Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  6. T(½) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  7. CL/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]
  8. Vz/F of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide) [ Time Frame: 0 to 30 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692781


Locations
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Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
OPKO Health, Inc.
Tel-Aviv Sourasky Medical Center
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT02692781    
Other Study ID Numbers: CP-6-001
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Keywords provided by OPKO Health, Inc.:
Obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight