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Unknown

MAD Cohorts 1 to 4: Participants receiving ECC5004 for Type 2 Diabetes

Phase 1
Recruiting
Research Sponsored by Eccogene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment
Not taking any active treatment regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sad: up to day 8 and mad: up to day 35
Awards & highlights

Study Summary

This trial is testing a new drug to help treat Type 2 Diabetes in healthy & diabetic participants. It's a safe & controlled study.

Eligible Conditions
  • Type 2 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are not currently receiving any medical treatment.
Select...
Your body mass index (BMI) falls between 18 and 32 kilograms per square meter.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sad: up to day 8 and mad: up to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and sad: up to day 8 and mad: up to day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Secondary outcome measures
Pharmacodynamic Parameters: AUC0-4 for C-peptide
Pharmacodynamic Parameters: AUC0-4 for glucagon
Pharmacodynamic Parameters: AUC0-4 for glucose
+19 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1 to 2: Participants receiving ECC5004Experimental Treatment1 Intervention
Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.
Group II: MAD Cohorts 1 to 4: Participants receiving ECC5004Experimental Treatment1 Intervention
Participants will be randomized to receive a once-daily dose of 1 of 4 escalating doses of ECC5004 ranging from 10 mg to 150 mg for 28 days.
Group III: MAD Cohorts 1 to 4: Participants receiving PlaceboPlacebo Group1 Intervention
Participants will be randomized to receive a once-daily dose of placebo for 28 days.
Group IV: SAD Cohorts 1 to 2: Participants receiving PlaceboPlacebo Group1 Intervention
Participants in each SAD cohort will be randomized to receive placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

EccogeneLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

ECC5004 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05654831 — Phase 1
Type 2 Diabetes Research Study Groups: MAD Cohorts 1 to 4: Participants receiving ECC5004, MAD Cohorts 1 to 4: Participants receiving Placebo, SAD Cohorts 1 to 2: Participants receiving ECC5004, SAD Cohorts 1 to 2: Participants receiving Placebo
Type 2 Diabetes Clinical Trial 2023: ECC5004 Highlights & Side Effects. Trial Name: NCT05654831 — Phase 1
ECC5004 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654831 — Phase 1

Frequently Asked Questions

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

Is the age range for this medical experiment limited to those over 25?

"This research study is open to individuals between the ages of 18 and 70. Additionally, there are 195 studies available for those under eighteen years old and 1,124 trials designed with seniors above 65 in mind."

Answered by AI

Are enrollees currently being accepted to participate in this clinical experiment?

"Per clinicaltrials.gov, this trial is actively recruiting patients with the original post date being December 1st 2022 and a subsequent edit on December 8th 2022."

Answered by AI

How many people are currently participating in this clinical experiment?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial has been actively seeking participants since December 1st 2022 and is currently recruiting 64 patients from one location."

Answered by AI

Has the FDA granted authorization for Cohorts 1 to 2 participants to receive ECC5004 as a treatment for SAD?

"SAD Cohorts 1 to 2: Participants receiving ECC5004 received a score of 1, as Phase 1 trials typically indicate limited data regarding safety and efficacy."

Answered by AI

Are there any restrictions to joining this clinical trial?

"This clinical study is seeking 64 volunteers, aged 18-70 years old, who are diagnosed with type 2 diabetes mellitus. Additional criteria include a BMI of 18.0 - 32.0 kg/m2 and hemoglobin A1c ≤ 6.0% for all participants and postmenopausal status (or accepted true abstinence) in female patients as well as contraception use or abstention from intercourse in male applicants. Furthermore, physical examinations must be within normal parameters as indicated by vital sign measurements, ECG readings, laboratory tests results, medical history assessments and psychiatric evaluations; eligible candidates must also demonstrate the capacity to comprehend an informed consent document"

Answered by AI
~28 spots leftby Mar 2025