AzTrials
AzTrials

Obesity & OverweightPhase 2NCT07570758

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

A Phase 2 study testing ERX1000 in people with Obesity & Overweight, run by ERX Pharmaceuticals at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objective is to assess the safety and tolerability of oral dose ERX1000 in obese subjects. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity & Overweight
What is being tested?
ERX1000
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
3 sitesUnited States
Study dates
28 May 2026to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
Show all 14Show fewer
  • Hemoglobin A1c (HbA1c) ≤6.4%
  • Fasting glucose ≤125 mg/dL (≤6.94 mmol/L)
  • No history of ketoacidosis or hyperosmolar coma
  • Female subjects must not be pregnant or lactating. Nonpregnancy will be confirmed for all females by a urine pregnancy test conducted at Screening and at the Baseline Visit prior to enrollment into the study.
  • If of childbearing potential, the subject agrees to the use two of the following accepted contraceptive regimens from Screening to the first administration of the study drug, during the study, and for at least 30 days after the last dose of the study drug. Acceptable methods of contraception includes one of the following:
  • Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch), OR
  • Intrauterine device (with or without hormones), AND
  • Agrees to use a barrier method (e.g., male or female condom) during the study and for at least 30 days after the last dose of the study drug.

Who cannot join

  • 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.
Show all 52Show fewer
  • 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).
  • Type 1 diabetes mellitus or Type 2 diabetes mellitus or current or recent use of insulin (more than 1 week within 3 months prior to screening).
  • Obesity induced by other endocrine disorders (e.g., Prader-Willi syndrome, Cushing's syndrome).
  • Active autoimmune disease who are currently using or will likely require systemic glucocorticoid therapy in the next 6 months.
  • Any previous surgical treatment or procedures with medical devices (such as insertion of lap band or gastric balloons) for obesity (excluding liposuction if performed > 1 year prior to screening).
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair > 6 months prior to Screening will be allowed).
  • Uncontrolled endocrine disorders (e.g., Cushing syndrome, Addison's, Hashimoto's, hypothyroidism, hypogonadism).
  • Clinically significant and abnormal screening hematology lab results or recurring infections, or if any of the following are observed regardless of the Investigator's assessment of clinical significance (laboratory tests may be repeated once for confirmation of out-of-range values):
  • Hemoglobin <10 g/dL (<100 g/L)
  • Absolute neutrophil count (ANC) <2000/mm3
  • Platelets <135 x 109/L
  • ALT or AST > 1.5 ULN
  • GGT, ALP, total bilirubin, or INR > ULN
  • Results of screening clinical laboratory tests (complete blood count [CBC] with differential and platelets, chemistry, and urinalysis profile) and electrocardiogram (ECG) outside normal range and considered to be clinically significant by the Investigator.
  • Body weight of > 350 pounds (158.8 kilograms) due to weight limits of the DEXA scanner.
  • Current use, or within the 30 days prior to screening, of the following atypical antipsychotic medications:
  • Olanzapine
  • Clozapine
  • Quetiapine
  • Subjects on the following systemic concomitant medications who have not been on stable dose (or stable weight-based dose), defined as no more than ±25% variation in dose, for at least 3 months prior to study entry:
  • Vasopressin
  • Thyroid hormone
  • Testosterone
  • Other hormone or hormone replacement therapies
  • Anti-diabetes medications other than metformin (e.g., glucagon-like peptide-1 [GLP-1] receptor agonists, sodium-glucose linked transporter 2 (SGLT2) inhibitors, sulfonylureas)
  • Modafinil
  • Atypical anti-psychotics, other than those noted above
  • Anti-depressives
  • Attention deficit hyperactivity disorder (ADHD) medications
  • Subjects on any prescription or over-the-counter anti-obesity agents in the 3 months prior to screening (e.g., Saxenda, Wegovy, Zepbound, Xenical, Acutrim, Qsymia, Adipex, compounded peptides).
  • Chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within 1 month prior to study screening.
  • Vital signs unstable, or with the following values:
  • Systolic blood pressure >160 mm Hg
  • Diastolic blood pressure >100 mm Hg
  • Pulse rate >100 beats per minute (bpm)
  • Recent (within the last year) and/or recurrent history of autonomic dysfunction (e.g., unexplained syncope or palpitations).
  • Current or anticipated chronic use (more than 2 days) of narcotics or opiates.
  • 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.
  • Participation in any clinical study with an investigational drug/device within 3 months.
  • Positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) prior to initiation of dosing with study drug.
  • Serious adverse reaction or hypersensitivity to any drug which the Investigator believes is clinically significant and relevant to study participation.
  • Significant blood loss or blood donation >500 mL within 3 months.
  • Females who are pregnant, nursing, or intend to become pregnant during the study.
  • Subjects who are planning or likely to undergo surgery during the course of the study.
  • 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.).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Director of Patient Recruitment and Marketing contact

908-952-6877

recruitment@monroeresearch.com

United States3 sites, 3 recruiting

  • Monroe Biomedical Research

    Louisville, Kentucky, 40213

    Harold Bays, MD

    Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    Awawu Igbinadolor, MD

    Recruiting

  • Monroe Biomedical Research

    North Charleston, South Carolina, 29406

    Gregory J Feldman, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess Efficacy, Safety and Tolerability of Orally Administered ERX1000 in Subjects With Obesity

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

Being tested
ERX1000, Placebo
Keywords
Obesity
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERX1000Drug

    2mg tablet administered orally twice weekly.

  • PlaceboOther

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

Study groups in NCT07570758
Study groupRoleWhat they receive
Treatment ArmActive comparatorThis arm will receive oral doses of ERX1000.
Receives: Drug: ERX1000
Placebo ArmPlacebo comparatorThis arm will receive placebo doses.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (4)

  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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: From enrollment to Week 20.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start28 May 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07570758
Sponsor's protocol ID
ERX1000-O-100
Status last verified
Jun 2026
First submitted
30 Apr 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ERX1000 in people with Obesity & Overweight, run by ERX Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Director of Patient Recruitment and Marketing (908-952-6877, recruitment@monroeresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07570758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in