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

NCT05925920 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-11-05

No results posted yet for this study

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

Interventions

DRUG

ENT-03

single dose of active drug

DRUG

Placebo

single dose of placebo comparator

Sponsors & Collaborators

  • Metabolics Pharma

    lead INDUSTRY

Principal Investigators

  • Richard Larson, MD · Enterin Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-08-12
Completion
2024-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05925920 on ClinicalTrials.gov