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Recruiting NCT07570758

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

Conditions: Obesity & Overweight

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: ERX Pharmaceuticals

Location: Monroe Biomedical Research Louisville Kentucky

Summary

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

Eligibility Criteria

Inclusion Criteria: 1. Able to comprehend and willing to sign an ICF and to abide by the study requirements. 2. Male and female subjects ages 18-60 years, inclusive. 3. BMI \>30 to \480 msec for females pre-dose on Day 1. 3. 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. 4. 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 (\160 mm Hg 2. Diastolic blood pressure \>100 mm Hg 3. Pulse rate \>100 beats per minute (bpm) 19. Recent (within the last year) and/or recurrent history of autonomic dysfunction (e.g., unexplained syncope or palpitations). 20. Current or anticipated chronic use (more than 2 days) of narcotics or opiates. 21. Significant history of abuse of drugs or solvents in the year before screening, or history of alcohol abuse in the past year before screening or currently drinks in excess of 21 units or servings per week. 22. Participation in any clinical study with an investigational drug/device within 3 months. 23. Positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) prior to initiation of dosing with study drug. 24. Serious adverse reaction or hypersensitivity to any drug which the Investigator believes is clinically significant and relevant to study participation. 25. Significant blood loss or blood donation \>500 mL within 3 months. 26. Females who are pregnant, nursing, or intend to become pregnant during the study. 27. Subjects who are planning or likely to undergo surgery during the course of the study. 28. Subject is, in the opinion of the Investigator, not suitable to participate in the study (e.g., clinically significant illness in the 8 weeks before screening; unable to commit to study visits, etc.).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07570758). StuddyBuddy aggregates publicly available trial information.