← Back to Search

Other

Subcutaneous ENT-03 for Type 2 Diabetes

Phase 1
Recruiting
Research Sponsored by Enterin Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 24 hours, 48 house, 72 hours
Awards & highlights

Study Summary

This trial tests the safety of a new drug in healthy and Type 2 diabetic obese people, to see how it affects their body.

Who is the study for?
This trial is for adults aged 18-70 with obesity (BMI 30-35) and/or Type 2 diabetes, who are generally healthy. Women must use double-barrier contraception or be of non-child-bearing potential; men must agree to use condoms. Participants should not have had significant weight changes recently, no severe psychiatric disorders or substance abuse, and cannot be on certain medications affecting body weight.Check my eligibility
What is being tested?
The study tests ENT-03 against a placebo in obese individuals and those with Type 2 diabetes. It's a single-center trial where participants receive one dose randomly assigned to either the drug or placebo group. The effects on safety, tolerability, how the body processes the drug (pharmacokinetics), and its impact on the body (pharmacodynamics) will be observed.See study design
What are the potential side effects?
While specific side effects of ENT-03 are not listed here, common side effects in trials like this may include reactions at the injection site, gastrointestinal issues such as nausea or diarrhea, headaches, dizziness, fatigue or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 24 hours, 48 house, 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 24 hours, 48 house, 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of ENT-03
Safety and tolerability of ENT-03
Secondary outcome measures
effect on glucose
effect on insulin and insulin sensitivity
pharmacodynamic endpoint: body weight
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Receive a single dose of ENT-03 sub-cutaneously
Group II: PlaceboPlacebo Group1 Intervention
Receive a single dose of placebo sub-cutaneously

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Enterin Inc.Lead Sponsor
4 Previous Clinical Trials
228 Total Patients Enrolled
Denise BarbutStudy DirectorEnterin Inc.
Richard Larson, MDStudy DirectorEnterin Inc.
1 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

ENT-03 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05925920 — Phase 1
Obesity Research Study Groups: Active, Placebo
Obesity Clinical Trial 2023: ENT-03 Highlights & Side Effects. Trial Name: NCT05925920 — Phase 1
ENT-03 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05925920 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What has been the regulatory assessment of Active?

"There is limited data confirming the safety and efficacy of Active, which has earned it a score of 1."

Answered by AI

Is it feasible for me to take part in this experiment?

"Candidates for this clinical study must suffer from obesity and be within the 18-70 year old age range. A total of 49 participants are anticipated to take part in this trial."

Answered by AI

Are participants in this research project required to be of legal age?

"In order to participate in this medical trial, patients must fall within the age range of 18-70. There are separate trials available for those younger and older than these limits with 366 studies dedicated to minors and 1,618 designed for seniors."

Answered by AI

Are researcher currently accepting new participants in this scientific experiment?

"Affirmative. According to clinicaltrials.gov, the study is currently in search of 49 participants from a single location. The trial was first advertised on June 13th 2023 and revised lastly on June 22nd 2023."

Answered by AI

What aims are being sought through this research endeavor?

"The main goal of this 7 day medical trial is to assess the security and tolerability of ENT-03. Secondary objectives include examining its pharmacokinetics by measuring plasma concentration, time of maximum plasma concentration, and terminal elimination half life in patients' bloodstreams."

Answered by AI

What is the upper limit of individuals participating in this research?

"Yes, the records available on clinicaltrials.gov demonstrate that this medical study is presently recruiting patients. This trial was first launched on June 13th 2023 and has since seen its most recent updates by June 22nd of the same year. There are 49 individuals planned to be enrolled in this experiment from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes
2023. "Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05925920.
~11 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top