DelfaGLP-1 Atlas

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CompletedPhase 1

Phase Ib Clinical Study of HDM1005 Injection

A Randomized, Double-blind, Placebo-controlled, Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous (SC) Doses of HDM1005 Injection in Overweight or Obese Subjects

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

40

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Incidence, severity, and causality of treatment-emergent adverse events (TEAEs)

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 IDNCT06637020
Org study IDHDM1005-102

Timeline

Milestones

Study start2024-06-20actual
Study first posted2024-10-15actual
Primary completion2024-12-27actual
Study completion2025-02-14actual
Last update posted2025-12-16actual

Assets

Investigational agents

HDM1005

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Male or female subjects aged 18 to 65 years old (inclusive).
•BMI >27.0 kg/m² and < 40.0 kg/m² at screening and randomization.
•Blood pressure < 160/100 mmHg and pulse rate between 50-100 bpm (inclusive) at screening.
•Female subjects of childbearing potential must have used and agreed to continue using effective contraception methods for at least 14 days prior to signing the ICF and up to 2 months after dosing, and have no plans to have children or donate eggs. Male subjects must have no plans to have children or donate sperm from the date of signing the ICF to 4 months after dosing, and they must agree to use effective contraception methods.
•Able to understand the procedures and methods used in the study, voluntarily sign the ICF, and willing to strictly adhere to the requirements of the clinical trial protocol to complete the relevant procedures.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded:

•Within 3 months before screening, subjects' body weight changed by ≥5%
•Previously diagnosed with type 1, type 2, or another type of diabetes
•Diagnosis of overweight or obesity due to other diseases or medications
•History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
•As determined by the investigator, the subjects have co-existing diseases or conditions that affect gastric emptying or gastrointestinal nutrient absorption.
•Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
•Any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
•Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
•Previous or combined depression or other mental disorders
•Known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; Or have a history of severe drug allergies
•Use of GLP-1R agonists within 6 months before signing the ICF
•Drugs that have been used within 3 months before signing ICF and have been determined by researchers to significantly affect weight and glucose
•For subjects taking lipid-lowering drugs, the dose of lipid-lowering drugs was not stable within 30 days before signing the ICF
•Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)
•Any of the auxiliary test indicators during the screening period meets the following criteria:
a)Hemoglobin <100g/L for women and < 110g/L for men;
b)ALT>2.0x upper limit of normal (ULN), or AST>2.0x ULN, or ALP>1.5x ULN, or TBIL>1.5x ULN (Subjects with Gilbert's syndrome can participate in this study if DBIL≤ULN);
c)HbA1c≥6.5%, or fasting blood glucose ≥7.0 mmol/L or ≤3.9 mmol/L;
d)Triglyceride >5.6 mmol/L;
e)calcitonin ≥20 ng/L;
f)Thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L
g)blood amylase or lipase >ULN; h)eGFR < 90 mL/min/1.73m2; i) QTcF Male >450ms, female >470ms
•People tested positive for infectious diseases
•Habitual smokers, alcoholics and drug abusers
•Blood donors within 3 months prior to randomization
•Pregnant or lactating women
•The Investigator considers that the subject is not suitable to participate in any other circumstances of the trial

Endpoints (7)

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

Weight & body composition
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Glycemic / diabetes
1

Weight & body composition

2 endpoints
Other/protocol endpoint

Changes of weight in kilogram

Time frame:Baseline to day 29

descriptive

Other/protocol endpoint

BMI in kg/m^2

Time frame:Baseline to day 29

descriptive

Glycemic / diabetes

1 endpoint
Other/protocol endpoint

Changes of glucose

Time frame:Baseline to day 29

descriptive

Cardiometabolic biomarkers

2 endpoints
Other/protocol endpoint

Change of blood pressure

Time frame:Baseline to day 29

descriptive

Other/protocol endpoint

Change of Total cholesterol (blood lipid )

Time frame:Baseline to day 29

descriptive

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame:Signing informed until day 57

descriptive

Secondary/protocol endpoint

area under the concentration- time curve from time zero to time t (AUC0-t).

Time frame:Before the first dose to 672 hours after the last dose

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.