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Type 2 Diabetes MellitusPhase 1NCT05654831

FTIH of ECC5004 in Healthy and Diabetic Participants

A Phase 1 study testing ECC5004 in people with Type 2 Diabetes Mellitus, run by Eccogene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
ECC5004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
69 participants
Where
1 siteUnited States
Study dates
1 Dec 2022to 1 Nov 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female participants of non-childbearing potential
  • Age of 18 to 65 years
  • BMI of 18.0 to 32.0 kg/m2
  • Hemoglobin A1c ≤ 6.0%
  • Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence
  • Male participants agree to use contraception, or agree to practice true abstinence
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  • No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, laboratory tests, or medical/psychiatric history
  • Able to understand and sign and date informed consent
  • Additional Inclusion Criteria for Part 2 (MAD)
  • Diagnosed Type 2 Diabetes Mellitus of 18 to 70 years of age inclusive
  • Type 2 Diabetes Mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment
  • BMI of 24.0 to 40.0 kg/m2 with a minimum body weight of 50.0 kg (110 lbs)
  • HbA1c ≥ 7.0% and ≤ 10.5%, and fasting plasma glucose ≤ 270 mg/dL
  • Blood pressure (BP) with or without medication: Systolic BP ≤ 160 mmHg, AND Diastolic BP ≤ 100 mmHg
  • Not taking any active treatment regimen

Who cannot join

  • Concomitant participation in any investigational study of any nature
  • Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing
  • Unable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatment
  • Serum calcitonin > 20 ng/L
  • Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
  • Diagnosis of T1DM or secondary forms of diabetes
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  • Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
  • History of pancreatitis
  • Significant allergic reaction to active ingredients or excipients of the study drug.
  • Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eccogene Investigational Site

    Anaheim, California, 92801

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, First-Time-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients With Type 2 Diabetes Mellitus

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC5004 in healthy participants and in patients with Type 2 Diabetes Mellitus

Read the detailed description

This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 300mg, and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 10mg to 150mg to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC5004 in Healthy Participants and in Patients with Type 2 Diabetes Mellitus

Being tested
Placebo, ECC5004
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching Placebo will be administered as oral tablet. Matching Placebo will be given orally during each dosing day.

  • ECC5004Drug

    ECC5004 will be administered as oral tablet(s) during each dosing day.

Study groups in NCT05654831
Study groupRoleWhat they receive
SAD Cohorts 1 to 2: Participants receiving PlaceboPlacebo comparatorParticipants in each SAD cohort will be randomized to receive placebo.
Receives: Drug: Placebo
SAD Cohorts 1 to 2: Participants receiving ECC5004ExperimentalParticipants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.
Receives: Drug: ECC5004
MAD Cohorts 1 to 4: Participants receiving PlaceboPlacebo comparatorParticipants will be randomized to receive a once-daily dose of placebo for 28 days.
Receives: Drug: Placebo
MAD Cohorts 1 to 4: Participants receiving ECC5004ExperimentalParticipants 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.
Receives: Drug: ECC5004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations

    Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.

    Measured: SAD: Up to Day 8 and MAD: Up to Day 35

Secondary outcomes (22)

  1. Pharmacokinetic Parameters: AUC0-24

    AUC from time 0 to 24 hour dosing interval

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  2. Pharmacokinetic Parameters: AUC0-tlast

    AUC from time 0 to the time of last quantifiable non-zero concentration

    Measured: SAD: Up to Day 3

  3. Pharmacokinetic Parameters: AUC0-tau

    AUC over a dosing interval from time 0 to time of last quantifiable concentration

    Measured: MAD: Up to Day 30

  4. Pharmacokinetic Parameters: AUC0-infinity

    AUC from time 0 extrapolated to infinity

    Measured: SAD: Up to Day 3

  5. Pharmacokinetic Parameters: Cmax

    Maximum observed plasma concentration

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  6. Pharmacokinetic Parameters: C24

    Observed concentration at 24 hours post dose

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  7. Pharmacokinetic Parameters: Ctau

    Observed concentration at the end of the dosing interval

    Measured: MAD: Up to Day 30

  8. Pharmacokinetic Parameters: tmax

    Time of the maximum observed plasma concentration

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  9. Pharmacokinetic Parameters: tlag

    Lag time (time delay between dosing and first observed plasma concentration)

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  10. Pharmacokinetic Parameters: t1/2

    Apparent terminal elimination half-life

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  11. Pharmacokinetic Parameters: Clast

    Last measurable non-zero concentration

    Measured: SAD: Up to Day 3

  12. Pharmacokinetic Parameters: tlast

    Time of last measurable non-zero concentration

    Measured: SAD: Up to Day 3

  13. Pharmacokinetic Parameters: CL/F

    Apparent Clearance

    Measured: SAD: Up to Day 3 and MAD: Up to Day 30

  14. Pharmacodynamic Parameters: AUC0-4 for glucose

    AUC from time 0 to 4 hour dosing interval

    Measured: MAD: Up to Day 30

  15. Pharmacodynamic Parameters: AUC0-4 for insulin

    AUC from time 0 to 4 hour dosing interval

    Measured: MAD: Up to Day 30

  16. Pharmacodynamic Parameters: AUC0-4 for glucagon

    AUC from time 0 to 4 hour dosing interval

    Measured: MAD: Up to Day 30

  17. Pharmacodynamic Parameters: AUC0-4 for C-peptide

    AUC from time 0 to 4 hour dosing interval

    Measured: MAD: Up to Day 30

  18. Pharmacodynamic Parameters: Fasting plasma glucose

    Change from baseline

    Measured: MAD: Up to Day 30

  19. Pharmacodynamic Parameters: Mean daily glucose

    Change from baseline

    Measured: MAD: Up to Day 30

  20. Pharmacodynamic Parameters: Body Weight and Waist Circumference

    Change from baseline

    Measured: MAD: Up to Day 30

  21. Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment

    Fasting plasma glucose homeostatic model assessment

    Measured: MAD: Up to Day 30

  22. Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment

    Fasting plasma insulin homeostatic model assessment

    Measured: MAD: Up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2022
  2. Study start1 Dec 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05654831
Sponsor's protocol ID
EC0004
Status last verified
Jul 2024
First submitted
8 Dec 2022
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haggag AZ, Xu J, Butcher L, Pagnussat S, Davies G, Lundqvist S, Wang W, Van Zuydam N, Nelander K, Jha A, Yu H, Boianelli A, Lindmark B, Ollerstam A, Sun X, Wang F, Pan X, Liu H, Chen W, Xu J, Wallenius K, Zhou J. Non-clinical and first-in-human characterization of ECC5004/AZD5004, a novel once-daily, oral small-molecule GLP-1 receptor agonist. Diabetes Obes Metab. 2025 Feb;27(2):551-562. doi: 10.1111/dom.16047. Epub 2024 Nov 4.

    PubMed 39495140

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ECC5004 in people with Type 2 Diabetes Mellitus, run by Eccogene at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations (time frame: SAD: Up to Day 8 and MAD: Up to Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05654831, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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