Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes (NCT05925920) | Clinical Trial Compass
CompletedPhase 1
Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
United States49 participantsStarted 2023-06-13
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From Day 1 (dosing visit) through Day 14 (End of Study visit), approximately 3 to 4 weeks
2
Safety and Tolerability of ENT-03
Timeframe: Baseline (pre-dose Day 1), Day 4 (72 hours post-dose), and Day 8 (168 hours post-dose, End of Study)
. Subjects must have a BMI 30-35 kg/m2 inclusive assessed immediately prior to screening.
. Fasting insulin level ≥11 mIU/L.
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.