What is ERX1000 studying for obesity?

ERX1000 is being studied to assess its safety and tolerability in adults with obesity. Researchers aim to understand how this oral medication affects body weight and metabolic health. The study is sponsored by ERX Pharmaceuticals and compares ERX1000 with a placebo to evaluate its effects under medical supervision.

Who may be eligible for this obesity clinical trial?

Adults aged 18 to 60 years with a BMI between 30 and 50 kg/m2 may be eligible. Both men and women can participate, but pregnant or breastfeeding women are excluded. Participants should have stable body weight and diet for at least 3 months. Please review eligibility criteria for more details.

Is there any cost to participate in this obesity clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for potential costs related to travel and accommodations.

Actively Recruiting

Phase 2

Age: 18Years - 60Years

All Genders

ID07570758

Phase 2A Study to Evaluate Safety and Effectiveness of Oral ERX1000 for Treating Obesity in Adults

Led by ERX Pharmaceuticals · Updated on 2026-06-22

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and tolerability of an oral drug called ERX1000 in adults with obesity. The study includes men and women aged 18 to 60 years with a body mass index BMI between 30 and 50 kgm2. The trial is a randomized, double-blind, placebo-controlled Phase 2A study designed to compare ERX1000 with a placebo in people living with obesity. Participants will be assigned to receive either ERX1000 or a placebo. ERX1000 is given as a 2 mg tablet taken orally twice a week. The treatment period lasts for 24 weeks, during which participants take the assigned tablets regularly. The study monitors safety and tolerability while assessing changes in body weight and other metabolic markers. Throughout the trial, participants will have regular assessments to measure changes in body weight, body composition, and metabolic biomarkers. Safety is monitored by tracking adverse events and laboratory tests including liver function. The primary measurement focuses on body weight changes from the start of treatment to weeks 12 and 24. Participation lasts about 28 weeks in total, including follow-up after treatment ends.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years

All Genders

Eligibility Criteria

You may qualify if you...

Able to understand and willing to sign informed consent and follow study rules.
Male or female aged 18 to 60 years.
Body mass index (BMI) greater than 30 and less than 50 kg/m2.
Stable body weight for 3 months with less than 5% change.
Stable diet or nutritional habits for at least 3 months before randomization.
For prediabetes diagnosis: Hemoglobin A1c 6.4% or less, fasting glucose 125 mg/dL or less, no ketoacidosis or hyperosmolar coma history.
Female participants must not be pregnant or breastfeeding and agree to use two types of contraception during and for 30 days after the study drug treatment.

You will not qualify if you...

Poorly controlled severe psychiatric disorders or recent psychotic episodes.
History of schizophrenia, schizoaffective disorder, or bipolar 1 disorder within 2 years.
History of bleeding disorders, deep vein thrombosis, or blood clots.
Current major liver, kidney, lung, heart, cancer, or gastrointestinal diseases.
Significant cardiovascular disease or abnormal heart rhythms.
Liver function tests over 1.5 times the upper normal limit or liver disease.
Moderate to severe kidney dysfunction.
Type 1 or type 2 diabetes or recent insulin use.
Obesity caused by endocrine disorders like Prader-Willi or Cushing's syndrome.
Active autoimmune disease requiring systemic steroids soon.
Past surgery or device treatment for obesity except liposuction over 1 year ago.
History of stomach or bowel surgery affecting drug absorption except minor surgeries over 6 months ago.
Uncontrolled endocrine disorders.
Abnormal blood counts or infections.
ECG or lab tests outside normal range deemed significant by investigator.
Body weight over 350 pounds due to scanner limits.
Recent use of certain antipsychotic medications.
Unstable doses of certain hormones or medications.
Use of anti-obesity drugs within 3 months before screening.
Recent systemic steroid therapy.
Unstable or high blood pressure or pulse rate.
Recent autonomic dysfunction or chronic narcotic use.
History of substance or alcohol abuse or excessive drinking.
Participation in other clinical trials within 3 months.
Positive tests for HIV, hepatitis B or C.
Serious drug allergies relevant to study.
Significant recent blood loss or donation.
Pregnant, nursing, or planning pregnancy during the study.
Planned surgery during the study.
Investigator judgment of unsuitability for participation.

Research Team

Director of Patient Recruitment and Marketing

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Phase 2A Study to Evaluate Safety and Effectiveness of Oral ERX1000 for Treating Obesity in Adults

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria