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

NCT05925920 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: ENT-03S-22-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (8)

• Safety and tolerability of ENT-03

  Adverse Events

  7 days

• Safety and Tolerability of ENT-03

  ECG: QTc analysis

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: body temperature

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: respiration rate

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: heart rate

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: systolic blood pressure measurements

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: diastolic blood pressure measurements

  7 days

• Safety and Tolerability of ENT-03

  Vital signs: body weight in kilograms

  7 days

Secondary Outcomes (13)

• 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

Study Arms (2)

Active

ACTIVE COMPARATOR

Receive a single dose of ENT-03 sub-cutaneously

Drug: ENT-03

Placebo

PLACEBO COMPARATOR

Receive a single dose of placebo sub-cutaneously

Drug: Placebo

Interventions

ENT-03 DRUG

single dose of active drug

Active

Placebo DRUG

single dose of placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Metabolics Pharma: lead

Study Sites (1)

ProSciento

San Diego, California, 91911, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Richard Larson, MD

  Enterin Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 29, 2023
• Study Start: June 13, 2023
• Primary Completion: August 12, 2024
• Study Completion: December 6, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)