DelfaGLP-1 Atlas

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CompletedPhase 1

XW004 To Evaluate the Safety, Tolerability, PK, and PD of Oral Ecnoglutide Tablet in Healthy Adults

A Phase 1, Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ecnoglutide Tablet in Healthy Adult Participants

Asset

Ecnoglutide (XW004)

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

87

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 22-32•Healthy volunteers

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious 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 IDNCT05184322
Org study IDSCW0503-1011

Timeline

Milestones

Study first posted2022-01-11actual
Study start2022-04-12actual
Primary completion2024-07-13actual
Study completion2025-03-25actual
Last update posted2025-09-10actual

Assets

Investigational agents

Ecnoglutide (XW004)

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria:

•Healthy male or female participants, aged 18 to 55 years (inclusive at the time of informed consenting);
•Participants must be in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before administration of study drug;
•Stable body weight for at least 3 months prior to Screening (i.e., <5% change) by self-declaration;
•Participants must have a Body Mass Index (BMI) ≥22.0 kg/m2 and <32.0 kg/m2 and weigh ≥55 kg at Screening (Cohorts 1A/1B to 3), or participants must have a BMI ≥30.0 kg/m2 and <40.0 kg/m2 and weigh ≥75 kg at Screening (Cohort 4, 5 and 6 only);

Key Exclusion Criteria:

•Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product (IP) or procedures or interfere with study assessments;
•Confirmed diagnosis of diabetes mellitus type 1, type 2, or of any other forms at any time, and/or occurrence of documented or suspected hypoglycaemic episodes within 12 months prior to Screening;
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2;

Endpoints (1)

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

1 endpoint
Primary/protocol endpoint

Number and percentage of treatment emergent adverse events (TEAEs) and serious adverse events (SAE)

Time frame:Up to 98 days

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

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.