Not Yet RecruitingPhase 2

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

80 participantsStarted 2026-05

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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%).
✓. Stable diet and/or nutritional lifestyle for 3 months prior to randomization.
✓. If a subject has current diagnosis of prediabetes, the following criteria must be met:
✓. Hemoglobin A1c (HbA1c) ≤6.4%
✓. Fasting glucose ≤125 mg/dL (≤6.94 mmol/L)

Exclusion criteria

✕. 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.
✕. Current liver, renal, pulmonary, cardiac, oncologic, or gastrointestinal (GI) disease including:
✕. 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.
✕. Fridericia-corrected QT interval (QTcF) \>460 msec for males and QTcF \>480 msec for females pre-dose on Day 1.
✕. Liver disease or liver function tests, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \>1.5 upper limit of normal (ULN), alkaline phosphatase (ALP) or serum bilirubin \> ULN, or history of underlying liver disease including, hepatic cirrhosis, alcoholic hepatitis, or confirmed diagnosis of NASH; nonalcoholic fatty liver disease with qualifying LFTs will be allowed.
✕. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents or moderate to severe renal dysfunction as defined by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation (\<60 mL/min/1.73m2).

What they're measuring

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

Timeframe: From enrollment to the end of treatment at Week 24.

Trial details

NCT IDNCT07570758

SponsorERX Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

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