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MOD-6031

Phase 1

Obesity | Small molecule | Metabolic |Opko Health Inc.|Last Updated: Sep 30, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

MOD-6031 · 1 trial · 1 indication

Phase 1 1
NCT02692781A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese SubjectsObesity
COMPLETED32 Analytics
PHASE1COMPLETED
A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Cohort 1EXPERIMENTAL20mg MOD-6031 / Placebo
Dose Cohort 2EXPERIMENTAL50mg MOD-6031 / Placebo
Dose Cohort 3EXPERIMENTAL100mg MOD-6031 / Placebo
Dose Cohort 4EXPERIMENTAL150mg MOD-6031 / Placebo
Dose Cohort 5EXPERIMENTAL200mg MOD-6031 / Placebo

Interventions

NameTypeDescription
MOD-6031DRUG -
Placebo controlOTHER -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 abnormalit...

Countries:Israel
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Frequently asked questions about MOD-6031

What is MOD-6031 used for?

MOD-6031 is an investigational small molecule being developed for the treatment of obesity. It is in Phase 1 clinical development and has been studied in healthy overweight or obese subjects. The drug is being developed by Opko Health Inc. and is intended to address metabolic conditions related to obesity.

What does MOD-6031 target?

MOD-6031 is a small molecule being developed for obesity, but its specific molecular target has not been disclosed. The drug is in Phase 1 clinical development and has been evaluated in a single-dose, dose-escalation study in healthy overweight or obese subjects. Further details about its mechanism of action are not available.

Who makes MOD-6031?

MOD-6031 is being developed by Opko Health Inc., a biopharmaceutical company listed on the stock exchange under the ticker OPK. The drug is an investigational small molecule for the treatment of obesity and is currently in Phase 1 clinical development.

What phase is MOD-6031 in?

MOD-6031 is in Phase 1 clinical development. It has completed one Phase 1 trial, a single-dose, dose-escalation study in healthy overweight or obese subjects. The drug is investigational and has not been approved by regulatory authorities. It is being developed for the treatment of obesity.

What clinical trials is MOD-6031 in?

MOD-6031 has one completed clinical trial, NCT02692781, titled "A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects." This Phase 1 study enrolled 32 male participants in Israel and was a controlled, randomized trial. The drug is being developed for obesity.