DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07502001

Not yet recruitingPhase 1

Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin

A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Influence of HDM1005 on Gastric Emptying and Drug-Drug Interaction of HDM1005 and Metformin, Atorvastatin, Warfarin, and Digoxin in Overweight/Obese Adult Chinese Subjects

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

42

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 24-35

Primary endpoints

•AUC•Cmax•Time of Cmax (Tmax)

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 IDNCT07502001
Org study IDHDM1005-104

Timeline

Milestones

Study first posted2026-03-30actual
Last update posted2026-03-30actual
Study start2026-04-08estimated
Primary completion2026-12-01estimated
Study completion2027-06-02estimated

Assets

Investigational agents

HDM1005

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Aged between 18 and 45 years (inclusive), regardless of gender.
•Male participants with body weight ≥50.0 kg, female participants with body weight ≥45.0 kg, and body mass index (BMI = weight [kg]/height² [m²]) within the range of 24.0 to 35.0 kg/m² (inclusive).
•In the opinion of the investigator, participants are in generally good health based on medical history, clinical laboratory tests, vital signs, 12-lead ECG results, and physical examination findings at screening.
•Provide signed informed consent form (ICF) prior to the trial, and have a thorough understanding of the trial content, procedures, and possible adverse reactions. Participants must be able to communicate well with the investigator, and understand and comply with the requirements of this study.

Exclusion criteria

•Participants with a medical history or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
•History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
•History of an acute episode of cholecystitis within 3 months prior to screening.
•Experienced severe hypoglycemic events or recurrent hypoglycemic events (≥3 hypoglycemic events per week, or other hypoglycemic events as judged by the investigator) within 3 months prior to screening.
•Blood donation, significant blood loss (≥400 mL), or use of blood products within 3 months prior to screening or between screening and the first dose.
•Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications, whichever is longer (excluding contraceptives).
•Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
•Female participants who are breastfeeding or pregnant.
•Participants with any other factors that, in the opinion of the investigator, make them unsuitable for participation in this trial (e.g., medical, psychological, or psychiatric conditions, social or geographical factors)

Endpoints (9)

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

9 endpoints
Primary/protocol endpoint

Area Under the Concentration Time Curve From Time Zero to ∞ [ AUC(0- ∞)]

Time frame:Up to Day 115

concentration, descriptive

Primary/protocol endpoint

Maximum observed concentration (Cmax)

Time frame:Up to Day 115

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]

Time frame:Up to Day 115

concentration, descriptive

Primary/protocol endpoint

Time of maximum observed concentration (Tmax)

Time frame:Up to Day 115

concentration, descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Up to Day 115

descriptive

Secondary/protocol endpoint

Apparent volume of distribution (Vz/F)

Time frame:Up to Day 115

descriptive

Secondary/protocol endpoint

Time of maximum observed concentration (Tmax)

Time frame:Up to Day 115

concentration, descriptive

Secondary/protocol endpoint

Maximum observed concentration (Cmax)

Time frame:Up to Day 115

concentration, descriptive

Secondary/protocol endpoint

Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]

Time frame:Up to Day 115

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.