DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05654831

CompletedPhase 1

FTIH of ECC5004 in Healthy and Diabetic Participants

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

Lead sponsor

Eccogene

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

69

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criteria

•BMI 18-32•HbA1c ≤6%•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any))

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05654831
Org study IDEC0004

Timeline

Milestones

Study start2022-12-01actual
Study first posted2022-12-16actual
Primary completion2023-11-01actual
Study completion2023-11-01actual
Last update posted2024-07-17actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•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

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

Exclusion criteria

•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.

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
15
Glycemic / diabetes
7
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Pharmacodynamic Parameters: Body Weight and Waist Circumference

Time frame:MAD: Up to Day 30

change from baseline, improvement

componentsBody weight, absolute change (kg), Waist circumference, change

Glycemic / diabetes

7 endpoints
Secondary/protocol endpoint

Pharmacodynamic Parameters: AUC0-4 for glucose

Time frame:MAD: Up to Day 30

Postprandial glucose

concentration, improvement

Secondary/protocol endpoint/low confidence

Pharmacodynamic Parameters: AUC0-4 for insulin

Time frame:MAD: Up to Day 30

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamic Parameters: AUC0-4 for C-peptide

Time frame:MAD: Up to Day 30

C-peptide AUC

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamic Parameters: Fasting plasma glucose

Time frame:MAD: Up to Day 30

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Pharmacodynamic Parameters: Mean daily glucose

Time frame:MAD: Up to Day 30

change from baseline, improvement

Secondary/protocol endpoint

Pharmacodynamic Parameters: Fasting plasma glucose homeostatic model assessment

Time frame:MAD: Up to Day 30

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Pharmacodynamic Parameters: Fasting plasma insulin homeostatic model assessment

Time frame:MAD: Up to Day 30

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

15 endpoints
Primary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any)

Secondary/protocol endpoint

Pharmacokinetic Parameters: AUC0-24

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

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: AUC0-tlast

Time frame:SAD: Up to Day 3

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: AUC0-tau

Time frame:MAD: Up to Day 30

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: AUC0-infinity

Time frame:SAD: Up to Day 3

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: Cmax

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

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: C24

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

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: Ctau

Time frame:MAD: Up to Day 30

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: tmax

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

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: tlag

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

descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: t1/2

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

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: Clast

Time frame:SAD: Up to Day 3

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: tlast

Time frame:SAD: Up to Day 3

descriptive

Secondary/protocol endpoint

Pharmacokinetic Parameters: CL/F

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

descriptive

Secondary/protocol endpoint

Pharmacodynamic Parameters: AUC0-4 for glucagon

Time frame:MAD: Up to Day 30

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.