NCT02692781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2016

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

February 4, 2016

Last Update Submit

September 27, 2019

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Composite safety and tolerability parameters as measured by adverse events, electrocardiograms (ECG), laboratory results, vital signs and injection site reactions

    30 days

Secondary Outcomes (8)

  • Cmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)

    0 to 30 days

  • Tmax of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)

    0 to 30 days

  • AUC(0-t) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)

    0 to 30 days

  • AUC(inf) of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)

    0 to 30 days

  • Elimination rate constant of MOD-6031 and its hydrolyzed derivatives (PEG-FMS and OXM peptide)

    0 to 30 days

  • +3 more secondary outcomes

Study Arms (5)

Dose Cohort 1

EXPERIMENTAL

20mg MOD-6031 / Placebo

Drug: MOD-6031Other: Placebo control

Dose Cohort 2

EXPERIMENTAL

50mg MOD-6031 / Placebo

Drug: MOD-6031Other: Placebo control

Dose Cohort 3

EXPERIMENTAL

100mg MOD-6031 / Placebo

Drug: MOD-6031Other: Placebo control

Dose Cohort 4

EXPERIMENTAL

150mg MOD-6031 / Placebo

Drug: MOD-6031Other: Placebo control

Dose Cohort 5

EXPERIMENTAL

200mg MOD-6031 / Placebo

Drug: MOD-6031Other: Placebo control

Interventions

MOD-6031DRUG
Dose Cohort 1Dose Cohort 2Dose Cohort 3Dose Cohort 4Dose Cohort 5
Placebo controlOTHER
Dose Cohort 1Dose Cohort 2Dose Cohort 3Dose Cohort 4Dose Cohort 5

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

December 15, 2016

Study Completion

December 15, 2016

Last Updated

September 30, 2019

Record last verified: 2019-09

Locations

IL(1)