Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2101
Source ID: NCT05925920
Associated Drug: Ent-03
Title: Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Obesity|Diabetes Mellitus, Type 2
Interventions: DRUG: ENT-03|DRUG: Placebo
Outcome Measures: Primary: Safety and tolerability of ENT-03, Adverse Events, 7 days|Safety and Tolerability of ENT-03, ECG: QTc analysis, 7 days|Safety and Tolerability of ENT-03, Vital signs: body temperature, 7 days|Safety and Tolerability of ENT-03, Vital signs: respiration rate, 7 days|Safety and Tolerability of ENT-03, Vital signs: heart rate, 7 days|Safety and Tolerability of ENT-03, Vital signs: systolic blood pressure measurements, 7 days|Safety and Tolerability of ENT-03, Vital signs: diastolic blood pressure measurements, 7 days|Safety and Tolerability of ENT-03, Vital signs: body weight in kilograms, 7 days | Secondary: pharmacokinetic endpoints: maximum plasma concentration, maximum measured plasma concentration, pre-dose, 24 hours, 48 house, 72 hours|pharmacokinetic endpoints: time of maximum plasma concentration, time of maximum measured plasma concentration, pre-dose, 24 hours, 48 house, 72 hours|pharmacokinetic endpoints: ENT-03 half-life, terminal elimination of ENT-03 half-life in plasma, pre-dose, 24 hours, 48 house, 72 hours|pharmacokinetic endpoints: plasma concentration, area under the concentration versus time curve over 24 hours, pre-dose, 24 hours, 48 house, 72 hours|pharmacokinetic endpoint: ENT-03 clearance, Clearance of ENT-03, pre-dose, 24 hours, 48 house, 72 hours|pharmacokinetic endpoint: elimination phase, slope of terminal elimination phase, pre-dose, 24 hours, 48 house, 72 hours|pharmacodynamic endpoint: glucose, change from screening visit in fasting plasma glucose, 7 days|pharmacodynamic endpoint: insulin, change from screening visit in fasting serum insulin, 7 days|pharmacodynamic endpoint: fasting lipids, change from screening visit in fasting lipids, 7 days|pharmacodynamic endpoint: fasting leptin, change from screening visit in fasting leptin, 7 days|pharmacodynamic endpoint: body weight, change from screening visit in body weight (kg), 7 days|effect on glucose, results of fasting and post-prandial blood glucose in subjects with obesity and T2D, Days -7, 2, 3, 4, and 7|effect on insulin and insulin sensitivity, results of fasting and post-prandial blood insulin and insulin sensitivity as measured by homeostatic assessment of insulin resistance (HOMAIR), in subjects with obesity and T2D, Days -7, 2, 3, 4, and 7
Sponsor/Collaborators: Sponsor: Metabolics Pharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2023-06-13
Completion Date: 2024-12-06
Results First Posted:
Last Update Posted: 2024-11-05
Locations: ProSciento, San Diego, California, 91911, United States
URL: https://clinicaltrials.gov/show/NCT05925920