At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 49 enrolled / 49 target
Drug / intervention
ENT-03 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating ENT-03 and Placebo for Obesity and Diabetes Mellitus, Type 2. Completed, enrolled 49 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Diabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartJun 2023
First PostedJun 2023
Primary CompletionAug 2024
TodayJul 2026
First PostedJun 29, 2023
Enrollment StartJun 13, 2023
Primary CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.0 years ago
Arms & Interventions
Activeactive_comparator
Receive a single dose of ENT-03 sub-cutaneously
Drug: ENT-03
Placeboplacebo_comparator
Receive a single dose of placebo sub-cutaneously
Drug: Placebo
Interventions
ENT-03drug
single dose of active drug
Placebodrug
single dose of placebo comparator