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A Phase 2A Clinical Trial to Assess the Safety and Tolerability of ERX1000 in Men and Women for the Treatment of Obesity.

ConditionObesity & Overweight
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorERX Pharmaceuticals

About this trial

The primary objective is to assess the safety and tolerability of oral dose ERX1000 in obese subjects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to comprehend and willing to sign an ICF and to abide by the study requirements.

Male and female subjects ages 18-60 years, inclusive.

BMI >30 to <50 kg/m2

Stable body weight for 3 months (self-reported loss/gain <5%).

Disqualifiers

Poorly controlled severe psychiatric disorders (e.g., bipolar disorder, or major depressive disorder), recent (within 6 months) psychotic episodes, history of suicide attempts or suicidal ideation, or any other psychiatric disorders that the Investigator believes will interfere significantly with study compliance.

Lifetime history of DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Diagnosis of bipolar 1 disorder within the previous 2 years.

History of any bleeding disorders, deep vein thrombosis (DVT), or thromboembolic disease.

Significant cardiovascular disease including history of congestive heart failure (CHF), coronary artery disease, myocardial infarction (MI), second degree or greater heart block, prolonged time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) syndrome, or clinically significant arrhythmias.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ERX1000

    Drug

    2mg tablet administered orally twice weekly.

  • Placebo

    Other intervention

    2mg Placebo tablet identical in appearance to 2mg ERX1000 tablet

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Treatment ArmActive comparator 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Body Weight of Participants from Baseline to Weeks 12 and 24

Time frame
From enrollment to the end of treatment at Week 24.

Secondary outcomes

1

Number of subjects with Adverse Safety Parameters

The number of participants with (1) treatment related adverse events; (2) adverse changes in vital signs; (3) adverse changes in 12-lead ECG results; (4) adverse changs in safety laboratory results; (5) adverse changes as observed though physical examinations

Time frame
From enrollment to the end of study participation at Week 28.
2

Change in Body Composition in Participants

(1) Change in % body fat by DEXA) from baseline to Weeks 12 and 24; (2) Change in BMI from baseline to Weeks 12 and 24; (3) Change in waist circumference from baseline to Weeks 12 and 24.

Time frame
From enrollment to the end of treatment at Week 24.
3

Change in Metabolic Biomarkers

1. Change in fasting lipid profile from baseline to Weeks 12 and 24: total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), and triglycerides; 2. Change in plasma biomarkers from baseline to Weeks 12 and 24: leptin, insulin, glucose, and HbA1c

Time frame
From enrollment to the end of treatment at Week 24.
4

Relationship Between Peak Drug Exposure and LFT Elevations

Number of participants with elevated LFT results concurrent with peak concentration of ERX1000.

Time frame
From enrollment to Week 20.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ERX Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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