Phase 1
N=49
Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
Obesity · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT05925920 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 1; 2; 3; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ENT-03 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Metabolics Pharma
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
1; 2; 3; 4; 3; 2 | — |
| PRIMARY Safety and Tolerability of ENT-03 |
-3.0; -14.0; -8.8; -9.2; -0.6; -4.2 | — |
| SECONDARY Pharmacokinetic Endpoints: Maximum Plasma Concentration |
624.81; 1245.40; 2612.00; 4860.00; 11042.00; 11002.00 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours Post-Dose (AUC₀-₂₄) |
9,801.4; 19841.6; 43206.2; 84534.5; 179984.5; 179575.0 | — |
| SECONDARY Pharmacokinetic Endpoint: Half-life |
29.1; 27.5; 45.8; 52.8; 66.1; 52.0 | — |
| SECONDARY Change in Body Weight From Baseline to Day 8 |
-0.54; -0.83; -0.55; -0.54; -0.83; -0.55 | — |
| SECONDARY Pharmacodynamic Endpoint: Change in Fasting Leptin From Baseline to Day 8 |
3.20; 0.46; -7.88; 2.04; -10.00; 4.66 | — |
| SECONDARY Pharmacodynamic Endpoint: Change in Fasting Plasma Glucose From Baseline to Day 8 |
9.4; -4.8; -1.2; 2.6; -2.6; 12.8 | — |
| SECONDARY Pharmacodynamic Endpoint: Change in Fasting Serum Insulin From Baseline to Day 8 |
3.06; 2.76; 4.48; 10.08; 2.70; 1.10 | — |
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 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 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 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
- Cyproheptadine or medroxyprogesterone
- Atypical anti-psychotic drugs
- Tricyclic antidepressants
- Lithium, MAO's, glucocorticoids
- SSRI's or SNRI's
- Antiepileptic drugs
- Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- A baseline prolongation of QT/QTc interval after repeated measurements of >450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
- Participation in an investigational drug trial within the month prior to dosing in the present study.
Data sourced from ClinicalTrials.gov (NCT05925920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.