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

Metabolics Pharma1 site in 1 country49 target enrollmentJune 13, 2023

ConditionsObesity Diabetes Mellitus, Type 2

InterventionsPlacebo ENT-03

DrugsENT-03 Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Obesity
Sponsor: Metabolics Pharma
Enrollment: 49
Locations: 1
Primary Endpoint: Safety and Tolerability of ENT-03
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 13, 2023

End Date

December 6, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Metabolics Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Arms & Interventions

Placebo

Receive a single dose of placebo sub-cutaneously

Intervention: Placebo

Active

Receive a single dose of ENT-03 sub-cutaneously

Intervention: ENT-03

Outcomes

Primary Outcomes

Safety and Tolerability of ENT-03

Time Frame: 7 days

Vital signs: body weight in kilograms

Safety and tolerability of ENT-03

Time Frame: 7 days

Adverse Events

Secondary Outcomes

pharmacokinetic endpoints: maximum plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
pharmacokinetic endpoints: time of maximum plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
pharmacokinetic endpoints: ENT-03 half-life(pre-dose, 24 hours, 48 house, 72 hours)
pharmacokinetic endpoints: plasma concentration(pre-dose, 24 hours, 48 house, 72 hours)
pharmacokinetic endpoint: ENT-03 clearance(pre-dose, 24 hours, 48 house, 72 hours)
pharmacokinetic endpoint: elimination phase(pre-dose, 24 hours, 48 house, 72 hours)
pharmacodynamic endpoint: glucose(7 days)
pharmacodynamic endpoint: insulin(7 days)
pharmacodynamic endpoint: fasting lipids(7 days)
pharmacodynamic endpoint: fasting leptin(7 days)
pharmacodynamic endpoint: body weight(7 days)
effect on glucose(Days -7, 2, 3, 4, and 7)
effect on insulin and insulin sensitivity(Days -7, 2, 3, 4, and 7)