DelfaGLP-1 Atlas

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CompletedPhase 1

ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of ECC5004 on the Single Dose Pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

Lead sponsor

Eccogene

Asset

AZD5004 / ECC5004

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

48

actual

Study population

Healthy volunteers

Key I/E criterion

•BMI 18-32

Primary endpoints

•Atorvastatin PK parameters•Rosuvastatin PK parameters•Digoxin PK parameters

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 IDNCT06293742
Org study IDEC0007

Timeline

Milestones

Study start2024-02-08actual
Study first posted2024-03-05actual
Primary completion2024-04-15actual
Study completion2024-04-15actual
Last update posted2024-07-22actual

Assets

Investigational agents

AZD5004 / ECC5004

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male and female participants of non-childbearing potential (NCBP) between the ages of 18 to 65 years of age
•BMI of 18.0 to 32.0 kg/m2
•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, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history
•Able to understand and sign and date informed consent

Exclusion criteria

•Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study
•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 treatment, or plan to donate blood during this trial and within 1 month after the last dose of 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
•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
•Used or plan to use any drugs or substances that can modulate the activity of CYP3A4 within at least 14 days prior to the first dose of study treatment until after their final follow up visit
•Use of drugs with enzyme-inducing properties such as St. John's Wort within 3 weeks prior to the first dose of study treatment until after their final follow up visit

Endpoints (43)

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.

Safety / tolerability / PK

43 endpoints
Primary/protocol endpoint

Atorvastatin PK parameters: AUC(0-tlast)

Time frame:Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Atorvastatin PK parameters: AUC(0-inf)

Time frame:Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Atorvastatin PK parameters: Cmax

Time frame:Part B and optional Part D: up to Day 34

Cmax

concentration, descriptive

Primary/protocol endpoint

Rosuvastatin PK parameters: AUC(0-tlast)

Time frame:Part A and optional Part C: up to Day 11

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Rosuvastatin PK parameters: AUC(0-inf)

Time frame:Part A and optional Part C: up to Day 11

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Rosuvastatin PK parameters: Cmax

Time frame:Part A and optional Part C: up to Day 11

Cmax

concentration, descriptive

Primary/protocol endpoint

Digoxin PK parameters: AUC(0-tlast)

Time frame:Part A and optional Part C: up to Day 11

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Digoxin PK parameters: AUC(0-inf)

Time frame:Part A and optional Part C: up to Day 11

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Digoxin PK parameters: Cmax

Time frame:Part A and optional Part C: up to Day 11

Cmax

concentration, descriptive

Primary/protocol endpoint

Midazolam PK parameters: AUC(0-tlast)

Time frame:Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Midazolam PK parameters: AUC(0-inf)

Time frame:Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Midazolam PK parameters: Cmax

Time frame:Part B and optional Part D: up to Day 34

Cmax

concentration, descriptive

Secondary/protocol endpoint

ECC5004 Safety parameters: Number of participants with adverse events (AEs)

Time frame:Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

ECC5004 Safety parameters: Number of participants with vital sign abnormalities

Time frame:Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities

Time frame:Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

ECC5004 Safety parameters: Number of participants with physical examination abnormalities

Time frame:Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40

descriptive

Secondary/protocol endpoint

ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities

Time frame:Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40

descriptive

Secondary/protocol endpoint

Atorvastatin safety parameters: Number of participants with adverse events (AEs)

Time frame:Part B and optional Part D: up to Day 40

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Atorvastatin safety parameters: Number of participants with vital sign abnormalities

Time frame:Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG)

Time frame:Part B and optional Part D: up to Day 40

descriptive

Secondary/protocol endpoint

Atorvastatin safety parameters: Number of participants with physical examination abnormalities

Time frame:Part B and optional Part D: up to Day 40

descriptive

Secondary/protocol endpoint

Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities

Time frame:Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

Rosuvastatin safety parameters: Number of participants with adverse events (AEs)

Time frame:Part A and optional Part C: up to Day 16

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Rosuvastatin safety parameters: Number of participants with vital sign abnormalities

Time frame:Part A and optional Part C: up to Day 16

event count, event

Secondary/protocol endpoint

Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities

Time frame:Part A and optional Part C: up to Day 16

event count, event

Secondary/protocol endpoint

Rosuvastatin safety parameters: Number of participants with physical examination abnormalities

Time frame:Part A and optional Part C: up to Day 16

descriptive

Secondary/protocol endpoint

Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities

Time frame:Part A and optional Part C: up to Day 16

descriptive, event

Secondary/protocol endpoint

Digoxin safety parameters: Number of participants with adverse events (AEs)

Time frame:Part A and optional Part C: up to Day 16

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Digoxin safety parameters: Number of participants with vital sign abnormalities

Time frame:Part A and optional Part C: up to Day 16

event count, event

Secondary/protocol endpoint

Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities

Time frame:Part A and optional Part C: up to Day 16

event count, event

Secondary/protocol endpoint

Digoxin safety parameters: Number of participants with physical examination abnormalities

Time frame:Part A and optional Part C: up to Day 16

descriptive

Secondary/protocol endpoint

Digoxin safety parameters: Number of participants with clinical laboratory abnormalities

Time frame:Part A and optional Part C: up to Day 16

descriptive

Secondary/protocol endpoint

Midazolam safety parameters: Number of participants with adverse events (AEs)

Time frame:Part B and optional Part D: up to Day 40

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Midazolam safety parameters: Number of participants with vital sign abnormalities

Time frame:Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities

Time frame:Part B and optional Part D: up to Day 40

descriptive, event

Secondary/protocol endpoint

Midazolam safety parameters: Number of participants with physical examination abnormalities

Time frame:Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

Midazolam safety parameters: Number of participants with clinical laboratory abnormalities

Time frame:Part B and optional Part D: up to Day 40

event count, event

Secondary/protocol endpoint

ECC5004 PK parameters: AUC (0-τ)

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: AUC(0-24)

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: tmax

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

Tmax

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: t1/2

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

Half-life

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: CL/F

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

descriptive

Secondary/protocol endpoint

ECC5004 PK parameters: Ctau

Time frame:Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34

Plasma concentration (steady state)

concentration, descriptive

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.