Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity, Diabetes Mellitus, Type 2

In brief

Single center, single-dose, randomized, placebo-controlled, dose-escalating study to evaluate, safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating doses of ENT-03S in obese but otherwise healthy subjects and in subjects with obesity and Type 2 diabetes.

Key facts

Study ID

NCT05925920

Run by

Metabolics Pharma

People needed

49

Starts

2023-06-13

Expected to finish

2024-08-12

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects aged 18-70 years, both genders.
• Healthy as determined by a physician, based on history, medical examination, vital signs, and laboratory tests.
• Males that agree to use condoms for the duration of participation in the study.
• Females of non-child-bearing potential (i.e., tubal ligation, hysterectomy, or postmenopausal).
• Female patients of child-bearing potential with negative serum pregnancy tests and who agree to use double-barrier contraception during the study.
• Subjects must be able to read, speak, and understand English and/or Spanish and provide written informed consent, and be willing and able to comply with study procedures.
• Subjects must have a BMI 30-35 kg/m2 inclusive assessed immediately prior to screening.
• Fasting insulin level ≥11 mIU/L.
• HbA1c < 8.5% (diabetic subjects only).
• Subjects with Type 2 diabetes on no anti-diabetic medication or on stable doses of metformin for 4 weeks or more (diabetic cohorts only).
• No history of active or chronic disease other than that allowed by study: hypertension, hyperlipidemia, hyperglycemia, GERD, heartburn, or Type 2 diabetes (cohorts 6 and 7 only).

You may not qualify if…

• History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use within the past three months, or failure on urinary drug screen.
• Pregnant or breastfeeding within six months of screening assessment.
• Substantial changes in eating habits or exercise routine within the preceding three months.
• Evidence of eating disorders.
• >5% weight change in the past three months.
• Bariatric surgery within the past five years.
• Significant renal impairment (eGFR <60 mg/mL/1.73m2).
• Patients on anti-diabetic medications other than metformin.
• Patients with gastroparesis.
• Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
• Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses).
• History of major depressive disorder within the previous two years, a lifetime history of suicide attempt, suicidal behavior within the previous month, or history of other severe psychiatric disorders.
• Score of >15 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• Use of medications affecting body weight within the past three months:
• Drugs approved for the treatment of obesity
• Cyproheptadine or medroxyprogesterone
• Atypical anti-psychotic drugs
• Tricyclic antidepressants
• Lithium, MAO's, glucocorticoids
• SSRI's or SNRI's
• Antiepileptic drugs
• Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• A baseline prolongation of QT/QTc interval after repeated measurements of >450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
• Participation in an investigational drug trial within the month prior to dosing in the present study.

Where it is running

• ProSciento — San Diego, California, United States

Full record on ClinicalTrials.gov

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