Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Receive a single dose of ENT-03 sub-cutaneously |
|
| Placebo | Placebo Comparator | Receive a single dose of placebo sub-cutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENT-03 | Drug | single dose of active drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Endpoints: Maximum Plasma Concentration | maximum measured plasma concentration | 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. |
Not provided
Inclusion 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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Larson, MD | Enterin Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento | San Diego | California | 91911 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (no T2D): ENT-03S 3 mg | Single subcutaneous dose of 3 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG001 | Cohort 2 (no T2D): ENT-03S 6 mg | Single subcutaneous dose of 6 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG002 | Cohort 3 (no T2D): ENT-03S 12.5 mg | Single subcutaneous dose of 12.5 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG003 | Cohort 4 (no T2D): ENT-03S 25 mg | Single subcutaneous dose of 25 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG004 | Cohort 5 (no T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG005 | Cohort 6 (T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG006 | Cohort 7 (T2D): ENT-03S 75 mg | Single subcutaneous dose of 75 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| FG007 | Placebo (All Cohorts) | Single subcutaneous dose of placebo administered across all 7 cohorts (Cohorts 1-5: subjects with obesity without Type 2 diabetes; Cohorts 6-7: subjects with obesity and Type 2 diabetes). Each cohort enrolled 2 placebo subjects using a 5:2 active:placebo randomization ratio with sentinel dosing. Placebo subjects from all cohorts are pooled in this arm as no active intervention was administered. Total N=14. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (no T2D): ENT-03S 3 mg | Single subcutaneous dose of 3 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks |
|
From informed consent signature through Day 14 (End of Study visit), approximately 3 to 4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 (no T2D): ENT-03S 3 mg | Single subcutaneous dose of 3 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 'Palpitations | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Larson, MD | MetabolicsPharma | NA | r.larson@metabolicspharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2024 | May 5, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
single dose of placebo comparator |
|
| 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 |
| 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 | 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. | 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. | 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. | 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. | Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study) |
| Cohort 2 (no T2D): ENT-03S 6 mg |
Single subcutaneous dose of 6 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG002 | Cohort 3 (no T2D): ENT-03S 12.5 mg | Single subcutaneous dose of 12.5 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG003 | Cohort 4 (no T2D): ENT-03S 25 mg | Single subcutaneous dose of 25 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG004 | Cohort 5 (no T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG005 | Cohort 6 (T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG006 | Cohort 7 (T2D): ENT-03S 75 mg | Single subcutaneous dose of 75 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| BG007 | Placebo (All Cohorts) | Single subcutaneous dose of placebo administered across all 7 cohorts (Cohorts 1-5: subjects with obesity without Type 2 diabetes; Cohorts 6-7: subjects with obesity and Type 2 diabetes). Each cohort enrolled 2 placebo subjects using a 5:2 active:placebo randomization ratio with sentinel dosing. Placebo subjects from all cohorts are pooled in this arm as no active intervention was administered. Total N=14. |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Cohort 2 (no T2D): ENT-03S 6 mg | Single subcutaneous dose of 6 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG002 | Cohort 3 (no T2D): ENT-03S 12.5 mg | Single subcutaneous dose of 12.5 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG003 | Cohort 4 (no T2D): ENT-03S 25 mg | Single subcutaneous dose of 25 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG004 | Cohort 5 (no T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG005 | Cohort 6 (T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG006 | Cohort 7 (T2D): ENT-03S 75 mg | Single subcutaneous dose of 75 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. |
| OG007 | Placebo (All Cohorts) | Single subcutaneous dose of placebo administered across all 7 cohorts (Cohorts 1-5: subjects with obesity without Type 2 diabetes; Cohorts 6-7: subjects with obesity and Type 2 diabetes). Each cohort enrolled 2 placebo subjects using a 5:2 active:placebo randomization ratio with sentinel dosing. Placebo subjects from all cohorts are pooled in this arm as no active intervention was administered. Total N=14. |
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | milliseconds | Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study) |
|
|
|
| Secondary | Pharmacokinetic Endpoints: Maximum Plasma Concentration | maximum measured plasma concentration | Posted | Mean | Standard Deviation | ng/mL | 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. |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | (hr*ng/mL) | 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) |
|
|
|
| Secondary | Pharmacokinetic Endpoint: Half-life | time required for drug concentration to decrease to 50% of maximum concentration | Posted | Mean | Standard Deviation | hours | Sampling through 72 hours post-dose (Cohorts 1-2), 120 hours (Cohort 3), and 168 hours (Cohorts 4-7). |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | KG | Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ug/mL | Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | μIU/mL | Baseline (pre-dose Day 1) and Day 8 (168 hours post-dose, End of Study) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Cohort 2 (no T2D): ENT-03S 6 mg | Single subcutaneous dose of 6 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | Cohort 3 (no T2D): ENT-03S 12.5 mg | Single subcutaneous dose of 12.5 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Cohort 4 (no T2D): ENT-03S 25 mg | Single subcutaneous dose of 25 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG004 | Cohort 5 (no T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) without Type 2 diabetes. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG005 | Cohort 6 (T2D): ENT-03S 50 mg | Single subcutaneous dose of 50 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG006 | Cohort 7 (T2D): ENT-03S 75 mg | Single subcutaneous dose of 75 mg ENT-03S administered to subjects with obesity (BMI 30-35 kg/m²) and Type 2 diabetes (HbA1c 6.5-8.5%), on no antidiabetic medications or stable metformin. Cohort enrolled using sentinel dosing (2 active:1 placebo), followed by remaining subjects at 5:2 active:placebo ratio. N=5. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG007 | Placebo (All Cohorts) | Single subcutaneous dose of placebo administered across all 7 cohorts (Cohorts 1-5: subjects with obesity without Type 2 diabetes; Cohorts 6-7: subjects with obesity and Type 2 diabetes). Each cohort enrolled 2 placebo subjects using a 5:2 active:placebo randomization ratio with sentinel dosing. Placebo subjects from all cohorts are pooled in this arm as no active intervention was administered. Total N=14. | 0 | 14 | 0 | 14 | 3 | 14 |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Gastroesophageal Reflux | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Injection Site Hemorrhage (Bruising) | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Peripheral Edema | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (26.0) | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
|
| Decreased Appettite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Postural Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
|
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| Day 4 |
|