ERX1000 - Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Male and Female Subjects With Obesity

Phase 1

Waitlist Available

Led By Irene Mirkin, MD

Research Sponsored by ERX Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new oral medication called ERX1000 to see if it is safe and can be tolerated by people who are obese.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ERX1000Experimental Treatment1 Intervention

ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.

Group II: PlaceboPlacebo Group1 Intervention

Reference product: Magnesium hydroxide carbonate powder prepared in an oral suspension

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ERX1000

2019

Completed Phase 1

~50

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