ObesityPhase 1NCT05925920

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

A Phase 1 study testing ENT-03 in people with Obesity and Diabetes Mellitus, Type 2, run by Metabolics Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Diabetes Mellitus, Type 2
What is being tested?: ENT-03
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 13 Jun 2023to 12 Aug 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

ProSciento
San Diego, California, 91911

Other trials in United States

About this study

Official title: 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

Conditions: Obesity, Diabetes Mellitus, Type 2
Being tested: ENT-03, Placebo
Medical subject headings: Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENT-03Drug
single dose of active drug
PlaceboDrug
single dose of placebo comparator

Study groups in NCT05925920
Study group	Role	What they receive
Active	Active comparator	Receive a single dose of ENT-03 sub-cutaneously Receives: Drug: ENT-03
Placebo	Placebo comparator	Receive a single dose of placebo sub-cutaneously Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study)

Secondary outcomes (7)

Pharmacokinetic Endpoints: Maximum Plasma Concentration
maximum measured plasma concentration
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 202312 Aug 2024

First posted29 Jun 2023
Study start13 Jun 2023
Primary completion12 Aug 2024
Study completion12 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05925920
Sponsor's protocol ID: ENT-03S-22-001
Status last verified: May 2026
First submitted: 5 Jun 2023
Last updated: 1 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05925920
Acronym / sponsor ID: ENT-03S-22-001
Conditions: Obesity, Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Metabolics PharmaIndustry (pharma, biotech, devices)
Study start: 13 Jun 2023 (actual)
Primary completion: 12 Aug 2024 (actual)
Study completion: 12 Aug 2024 (actual)
First posted: 29 Jun 2023 (actual)
Results: Posted 1 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ENT-03single dose of active drug	Drug	Active
Placebosingle dose of placebo comparator	Drug	Placebo

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks
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.
Safety and Tolerability of ENT-03
Time frame: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study)
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).

7 secondary outcomes

Pharmacokinetic Endpoints: Maximum 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)
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 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
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
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
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
Time frame: Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study)

Results and safety

Results posted to the registry on 1 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (no T2D): ENT-03S 3 mg	5	5
Cohort 2 (no T2D): ENT-03S 6 mg	5	5
Cohort 3 (no T2D): ENT-03S 12.5 mg	5	5
Cohort 4 (no T2D): ENT-03S 25 mg	5	5
Cohort 5 (no T2D): ENT-03S 50 mg	5	5
Cohort 6 (T2D): ENT-03S 50 mg	5	5
Cohort 7 (T2D): ENT-03S 75 mg	5	5
Placebo (All Cohorts)	14	12

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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

Measure	Cohort 1 (no T2D): ENT-03S 3 mg n = 5	Cohort 2 (no T2D): ENT-03S 6 mg n = 5	Cohort 3 (no T2D): ENT-03S 12.5 mg n = 5	Cohort 4 (no T2D): ENT-03S 25 mg n = 5	Cohort 5 (no T2D): ENT-03S 50 mg n = 5	Cohort 6 (T2D): ENT-03S 50 mg n = 5	Cohort 7 (T2D): ENT-03S 75 mg n = 5	Placebo (All Cohorts) n = 14
Value	1	2	3	4	3	2	1	4

Primary outcome: Safety and Tolerability of ENT-03

Time frame: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study). Mean (Standard Deviation). Unit: milliseconds

Measure	Cohort 1 (no T2D): ENT-03S 3 mg n = 5	Cohort 2 (no T2D): ENT-03S 6 mg n = 5	Cohort 3 (no T2D): ENT-03S 12.5 mg n = 5	Cohort 4 (no T2D): ENT-03S 25 mg n = 5	Cohort 5 (no T2D): ENT-03S 50 mg n = 5	Cohort 6 (T2D): ENT-03S 50 mg n = 5	Cohort 7 (T2D): ENT-03S 75 mg n = 5	Placebo (All Cohorts) n = 14
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)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From informed consent signature through Day 14 (End of Study visit), approximately 3 to 4 weeks. Other adverse events reported at 0% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Obesity

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Larson, MD study director

Enterin Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ENT-03 in people with Obesity and Diabetes Mellitus, Type 2, run by Metabolics Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05925920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.