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

A First in Human, Single Center, Single Dose, Randomized, Placebo-controlled, Dose, Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ENT-03S for the Treatment of Obesity and Diabetes

NCT05925920•Metabolics Pharma

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects aged 18-70 years, both genders.
•2. Healthy as determined by a physician, based on history, medical examination, vital signs, and laboratory tests.
•3. Males that agree to use condoms for the duration of participation in the study.
•4. Females of non-child-bearing potential (i.e., tubal ligation, hysterectomy, or postmenopausal).
•5. Female patients of child-bearing potential with negative serum pregnancy tests and who agree to use double-barrier contraception during the study.
•6. 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.
•7. Subjects must have a BMI 30-35 kg/m2 inclusive assessed immediately prior to screening.
•8. Fasting insulin level ≥11 mIU/L.
•9. HbA1c \< 8.5% (diabetic subjects only).
•10. Subjects with Type 2 diabetes on no anti-diabetic medication or on stable doses of metformin for 4 weeks or more (diabetic cohorts only).
+1 more criteria

Exclusion Criteria

•1. 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.
•2. Pregnant or breastfeeding within six months of screening assessment.
•3. Substantial changes in eating habits or exercise routine within the preceding three months.
•4. Evidence of eating disorders.
•5. \>5% weight change in the past three months.
•6. Bariatric surgery within the past five years.
•7. Significant renal impairment (eGFR \<60 mg/mL/1.73m2).
•8. Patients on anti-diabetic medications other than metformin.
•9. Patients with gastroparesis.
•10. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
+14 more criteria

Locations (1)

ProSciento

San Diego, California, United States

Key Dates

Start Date

June 13, 2023

Primary Completion Date

August 12, 2024

Completion Date

December 6, 2024

Last Updated

November 5, 2024

Enrollment

ACTUAL participants

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

ENT-03

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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