FTIH of ECC5004 in Healthy and Diabetic Participants

NCT05654831 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: EC0004
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (22)

• Pharmacokinetic Parameters: AUC0-24

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

• Pharmacokinetic Parameters: AUC0-tlast

  SAD: Up to Day 3

• Pharmacokinetic Parameters: AUC0-tau

  MAD: Up to Day 30

• Pharmacokinetic Parameters: AUC0-infinity

  SAD: Up to Day 3

• Pharmacokinetic Parameters: Cmax

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

Study Arms (4)

SAD Cohorts 1 to 2: Participants receiving Placebo

PLACEBO COMPARATOR

Participants in each SAD cohort will be randomized to receive placebo.

Drug: Placebo

SAD Cohorts 1 to 2: Participants receiving ECC5004

EXPERIMENTAL

Participants in each SAD cohort will be randomized to receive up to 4 escalating doses of ECC5004 ranging from 1 mg to 300 mg.

Drug: ECC5004

MAD Cohorts 1 to 4: Participants receiving Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive a once-daily dose of placebo for 28 days.

Drug: Placebo

MAD Cohorts 1 to 4: Participants receiving ECC5004

EXPERIMENTAL

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.

Drug: ECC5004

Interventions

Placebo DRUG

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

MAD Cohorts 1 to 4: Participants receiving Placebo; SAD Cohorts 1 to 2: Participants receiving Placebo

ECC5004 DRUG

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

MAD Cohorts 1 to 4: Participants receiving ECC5004; SAD Cohorts 1 to 2: Participants receiving ECC5004

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Eccogene: lead

Study Sites (1)

Eccogene Investigational Site

Anaheim, California, 92801, United States

Location

Related Publications (1)

• 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.

  PMID: 39495140 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eccogene

  Eccogene Clinical Trials

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)