CompletedNCT05925920Updated Jun 1, 2026Results posted

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

A Phase 1 interventional study of ENT-03 and Placebo in Obesity and Diabetes Mellitus, Type 2, sponsored by Metabolics Pharma. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Metabolics Pharma · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

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 studied

Obesity
Diabetes Mellitus, Type 2

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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 49 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

This is the only study on the registry with Metabolics Pharma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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).
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).

Exclusion criteria

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.
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
- 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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 49 participants (actual)

Study arms

Active comparator
Active
Receive a single dose of ENT-03 sub-cutaneously
Drug: ENT-03
Placebo comparator
Placebo
Receive a single dose of placebo sub-cutaneously
Drug: Placebo

Interventions

DrugENT-03
single dose of active drug
DrugPlacebo
single dose of placebo comparator

What researchers measure

Primary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment Emergent Adverse events (TEAEs) were collected from Day 1 (dosing visit ) through End of Study visit (Day 14 post-dose). TEAEs were defined as any AE with onset on or after the date of study drug administration. TEAEs were recorded by the investigator based on subject report, clinical observation, physical examination, vital signs, laboratory assessments, and ECG findings. Severity was graded per NCI CTCAE v5.0. Relatedness to study drug was assessed by the investigator. TEAEs of special interest included nausea, vomiting, and injection site reactions.
Time frame: From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks
Safety and Tolerability of ENT-03
QTcF (Fridericia-corrected QT interval) was assessed via 12-lead resting ECG at baseline (pre-dose Day 1) and at 72 hours post-dose (Day 4) and 168 hours post-dose (Day 8, End of Study).
Time frame: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study)

Secondary outcomes

Pharmacokinetic Endpoints: Maximum Plasma Concentration
maximum measured plasma concentration
Time frame: Pre-dose (0 hours) and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Note: Cohorts 1 and 2 had samples collected through 72 hours; Cohort 3 through 120 hours; Cohorts 4-7 through 168 hours.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours Post-Dose (AUC₀-₂₄)
area under the concentration versus time curve over 24 hours
Time frame: 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose (Cohorts 3-7); 0, 1, 2, 4, 8, 12, and 24 hours post-dose (Cohorts 1-2)
Pharmacokinetic Endpoint: Half-life
time required for drug concentration to decrease to 50% of maximum concentration
Time frame: Sampling through 72 hours post-dose (Cohorts 1-2), 120 hours (Cohort 3), and 168 hours (Cohorts 4-7).
Change in Body Weight From Baseline to Day 8
Body weight (kg) was measured at baseline (last measurement prior to first dose administration on Day 1) and at 168 hours post-dose (Day 8, End of Study). Change from baseline was calculated as the Day 8 value minus the baseline value.
Time frame: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Pharmacodynamic Endpoint: Change in Fasting Leptin From Baseline to Day 8
Fasting leptin (ng/mL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.
Time frame: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Pharmacodynamic Endpoint: Change in Fasting Plasma Glucose From Baseline to Day 8
Fasting plasma glucose (mg/dL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.
Time frame: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Pharmacodynamic Endpoint: Change in Fasting Serum Insulin From Baseline to Day 8
Fasting serum insulin (μIU/mL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.
Time frame: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)

Results

Posted Jun 1, 2026

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Started	5	5	5	5	5	5	5	14
Completed	5	5	5	5	5	5	5	12
Not completed	0	0	0	0	0	0	0	2
Withdrew: Withdrawal by subject	0	0	0	0	0	0	0	2

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

Treatment Emergent Adverse events (TEAEs) were collected from Day 1 (dosing visit ) through End of Study visit (Day 14 post-dose). TEAEs were defined as any AE with onset on or after the date of study drug administration. TEAEs were recorded by the investigator based on subject report, clinical observation, physical examination, vital signs, laboratory assessments, and ECG findings. Severity was graded per NCI CTCAE v5.0. Relatedness to study drug was assessed by the investigator. TEAEs of special interest included nausea, vomiting, and injection site reactions.

Time frame:: From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	1	2	3	4	3	2	1	4

PrimarySafety and Tolerability of ENT-03

QTcF (Fridericia-corrected QT interval) was assessed via 12-lead resting ECG at baseline (pre-dose Day 1) and at 72 hours post-dose (Day 4) and 168 hours post-dose (Day 8, End of Study).

Time frame:: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study)
Reported as:: Mean · milliseconds

Safety and Tolerability of ENT-03
milliseconds	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Day 8 (end of study)	-3.0 ± 20.16	-14.0 ± 15.75	-8.8 ± 24.69	-9.2 ± 22.84	-0.6 ± 24.99	-4.2 ± 9.86	-4.2 ± 25.38	-10.8 ± 20.75
Day 4	-7.4 ± 23.52	-16.0 ± 3.96	-6.8 ± 19.42	-6.4 ± 19.42	-3.4 ± 13.37	-13.4 ± 10.62	-4.0 ± 14.54	-4.0 ± 13.90

SecondaryPharmacokinetic Endpoints: Maximum Plasma Concentration

maximum measured plasma concentration

Time frame:: Pre-dose (0 hours) and at 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose. Note: Cohorts 1 and 2 had samples collected through 72 hours; Cohort 3 through 120 hours; Cohorts 4-7 through 168 hours.
Reported as:: Mean · ng/mL

Pharmacokinetic Endpoints: Maximum Plasma Concentration
ng/mL	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Pharmacokinetic Endpoints: Maximum Plasma Concentration	624.81 ± 113.90	1245.40 ± 282.40	2612.00 ± 173.40	4860.00 ± 375.60	11042.00 ± 1951.70	11002.00 ± 1962.70	12284.00 ± 2985.70	NA ± NA

SecondaryArea Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours Post-Dose (AUC₀-₂₄)

area under the concentration versus time curve over 24 hours

Time frame:: 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours post-dose (Cohorts 3-7); 0, 1, 2, 4, 8, 12, and 24 hours post-dose (Cohorts 1-2)
Reported as:: Mean · (hr*ng/mL)

Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours Post-Dose (AUC₀-₂₄)
(hr*ng/mL)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours Post-Dose (AUC₀-₂₄)	9,801.4 ± 2272.0	19841.6 ± 4264.3	43206.2 ± 3252.4	84534.5 ± 5604.1	179984.5 ± 35145.8	179575.0 ± 23127.7	217109.0 ± 40915.4	NA ± NA

SecondaryPharmacokinetic Endpoint: Half-life

time required for drug concentration to decrease to 50% of maximum concentration

Time frame:: Sampling through 72 hours post-dose (Cohorts 1-2), 120 hours (Cohort 3), and 168 hours (Cohorts 4-7).
Reported as:: Mean · hours

Pharmacokinetic Endpoint: Half-life
hours	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Pharmacokinetic Endpoint: Half-life	29.1 ± 3.1	27.5 ± 5.4	45.8 ± 9.5	52.8 ± 9.5	66.1 ± 13.0	52.0 ± 6.6	72.3 ± 7.1	NA ± NA

SecondaryChange in Body Weight From Baseline to Day 8

Body weight (kg) was measured at baseline (last measurement prior to first dose administration on Day 1) and at 168 hours post-dose (Day 8, End of Study). Change from baseline was calculated as the Day 8 value minus the baseline value.

Time frame:: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Reported as:: Mean · KG

Change in Body Weight From Baseline to Day 8
KG	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Change in Body Weight From Baseline to Day 8	-0.54 ± 0.68	-0.83 ± 1.30	-0.55 ± 0.89	-0.54 ± 0.81	-0.83 ± 1.30	-0.55 ± 0.89	0.59 ± 0.64	-0.52 ± 0.64

SecondaryPharmacodynamic Endpoint: Change in Fasting Leptin From Baseline to Day 8

Fasting leptin (ng/mL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.

Time frame:: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Reported as:: Mean · ug/mL

Pharmacodynamic Endpoint: Change in Fasting Leptin From Baseline to Day 8
ug/mL	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Pharmacodynamic Endpoint: Change in Fasting Leptin From Baseline to Day 8	3.20 ± 18.96	0.46 ± 3.28	-7.88 ± 8.83	2.04 ± 10.08	-10.00 ± 8.06	4.66 ± 7.50	-3.80 ± 9.14	-4.20 ± 11.47

SecondaryPharmacodynamic Endpoint: Change in Fasting Plasma Glucose From Baseline to Day 8

Fasting plasma glucose (mg/dL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.

Time frame:: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Reported as:: Mean · mg/dL

Pharmacodynamic Endpoint: Change in Fasting Plasma Glucose From Baseline to Day 8
mg/dL	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Pharmacodynamic Endpoint: Change in Fasting Plasma Glucose From Baseline to Day 8	9.4 ± 1.14	-4.8 ± 7.79	-1.2 ± 3.83	2.6 ± 9.48	-2.6 ± 4.10	12.8 ± 15.40	1.0 ± 11.81	-2.3 ± 11.44

SecondaryPharmacodynamic Endpoint: Change in Fasting Serum Insulin From Baseline to Day 8

Fasting serum insulin (μIU/mL) was measured at baseline (last measurement prior to first dose administration on Day 1) and at post-dose visits. For Cohorts 1-3, assessments were performed at 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 168 hours post-dose (Day 8, End of Study). For Cohorts 4-7, assessments were performed at 72 hours (Day 4) and 168 hours post-dose (Day 8, End of Study) only. Change from baseline was calculated as the visit value minus the baseline value.

Time frame:: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)
Reported as:: Mean · μIU/mL

Pharmacodynamic Endpoint: Change in Fasting Serum Insulin From Baseline to Day 8
μIU/mL	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
Pharmacodynamic Endpoint: Change in Fasting Serum Insulin From Baseline to Day 8	3.06 ± 4.06	2.76 ± 5.93	4.48 ± 4.23	10.08 ± 15.42	2.70 ± 4.56	1.10 ± 7.29	0.76 ± 5.47	0.99 ± 8.05

Adverse events

Collected over From informed consent signature through Day 14 (End of Study visit), approximately 3 to 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 (no T2D): ENT-03S 3 mg	0/5 (0%)	0/5 (0%)	1/5 (20%)
Cohort 2 (no T2D): ENT-03S 6 mg	0/5 (0%)	0/5 (0%)	2/5 (40%)
Cohort 3 (no T2D): ENT-03S 12.5 mg	0/5 (0%)	0/5 (0%)	5/5 (100%)
Cohort 4 (no T2D): ENT-03S 25 mg	0/5 (0%)	0/5 (0%)	4/5 (80%)
Cohort 5 (no T2D): ENT-03S 50 mg	0/5 (0%)	0/5 (0%)	4/5 (80%)
Cohort 6 (T2D): ENT-03S 50 mg	0/5 (0%)	0/5 (0%)	4/5 (80%)
Cohort 7 (T2D): ENT-03S 75 mg	0/5 (0%)	0/5 (0%)	3/5 (60%)
Placebo (All Cohorts)	0/14 (0%)	0/14 (0%)	3/14 (21.4%)

Most frequent other events

Showing 10 of 19

Most frequent other events
Event	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)
DiarrhoeaGastrointestinal disorders	0/5	0/5	1/5	1/5	3/5	2/5	0/5	1/14
Injection Site ErythemaGeneral disorders	0/5	0/5	0/5	3/5	0/5	0/5	0/5	0/14
HeadacheNervous system disorders	1/5	0/5	1/5	3/5	1/5	1/5	1/5	3/14
NauseaGastrointestinal disorders	1/5	0/5	0/5	1/5	2/5	0/5	0/5	1/14
'PalpitationsCardiac disorders	0/5	0/5	1/5	0/5	0/5	0/5	0/5	0/14
Abdominal DistensionGastrointestinal disorders	0/5	0/5	0/5	0/5	0/5	1/5	1/5	0/14
Abdominal PainGastrointestinal disorders	0/5	0/5	0/5	0/5	1/5	0/5	0/5	0/14
ConstipationGastrointestinal disorders	0/5	0/5	0/5	1/5	0/5	0/5	0/5	0/14
Gastroesophageal RefluxGastrointestinal disorders	0/5	0/5	0/5	0/5	1/5	0/5	0/5	0/14
VomitingGastrointestinal disorders	1/5	—	0/5	0/5	1/5	0/5	0/5	0/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
<=18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	5	5	5	4	5	3	3	12	42
>=65 years	0	0	0	1	0	2	2	2	7

Age, Continuous
Age, Continuous(years)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
Mean	51.7 ± 10.90	46.7 ± 11.51	50.4 ± 10.13	58.7 ± 8.00	50.3 ± 10.66	60.4 ± 5.22	54.7 ± 10.83	51.6 ± 10.98	54.0 ± 10.30

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
Female	2	2	2	3	4	4	2	5	24
Male	3	3	3	2	1	1	3	9	25

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0
Asian	0	0	0	1	0	0	0	0	1
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	1	0	0	1	4	6
White	5	4	5	2	4	4	3	8	35
More than one race	0	0	0	0	0	0	1	0	1
Unknown or Not Reported	0	1	0	1	1	1	0	2	6

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
Hispanic or Latino	4	3	3	2	3	4	2	7	28
Not Hispanic or Latino	1	2	2	3	2	1	3	7	21
Unknown or Not Reported	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Cohort 1 (no T2D): ENT-03S 3 mg	Cohort 2 (no T2D): ENT-03S 6 mg	Cohort 3 (no T2D): ENT-03S 12.5 mg	Cohort 4 (no T2D): ENT-03S 25 mg	Cohort 5 (no T2D): ENT-03S 50 mg	Cohort 6 (T2D): ENT-03S 50 mg	Cohort 7 (T2D): ENT-03S 75 mg	Placebo (All Cohorts)	Total
United States	5	5	5	5	5	5	5	14	49

Study locations

1 site

ProSciento
San Diego, California 91911, United States

References and documents

Study documents

Protocol and statistical analysis plan · May 20, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05925920
Lead sponsor: Metabolics Pharma
Responsible party: Sponsor
First posted: Jun 29, 2023
Start date: Jun 13, 2023
Primary completion: Aug 12, 2024
Completion: Aug 12, 2024
Results posted: Jun 1, 2026
Last update: Jun 1, 2026

Study contacts

Richard Larson, MD

study director · Enterin Inc.

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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