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Obesity and OverweightPhase 1NCT06640647

Phase Ia Clinical Study of HDM1005 Injection

A Phase 1 study of Obesity and Overweight, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase Ia clinical study. It is aimed to evaluate the safety, tolerability, PK and PD characteristics of HDM1005 injection in healthy adult subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Obesity and Overweight
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
1 siteChina
Study dates
19 Mar 2024to 26 Sep 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese subjects aged 18 to 55 (including 18 and 55 years old), male or female subjects
  • BMI at the time of screening was between 19.0 and 32.0 kg/m2 (including 19.0 and 32.0 kg/m2), and the weight of female subjects was ≥45 kg and that of male subjects was ≥50 kg
  • Normal or abnormal vital signs, physical examination, laboratory examination, 12-lead ECG and chest imaging during the screening period have no clinical significance
  • Fertile female subjects, from 14 days before signing the ICF to 2 months after the administration of the drug, have taken and agreed to continue to take effective contraceptive measures, and have no family planning or egg donation plan; Male subjects had no plans to have children, no plans to donate sperm, and agreed to use highly effective contraceptive methods from signing ICF to 4 months after dosing
  • Be able to understand the procedures and methods of this study, voluntarily sign ICF, and be willing to strictly follow the requirements of clinical trial protocol to complete relevant procedures

Who cannot join

  • Previous diagnosis of type 1, type 2, or other types of diabetes
  • History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
  • As determined by the investigator, the subject has a co-existing disease or condition that affects gastric emptying or gastrointestinal nutrient absorption. Or a history of acute pancreatitis or acute gallbladder disease within 3 months prior to signing the ICF
  • Had any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
  • 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
  • Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
Show all 19Show fewer
  • Known allergy to any component of the investigational drug or prior history of severe drug allergy
  • Drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, health products, etc.) that have been used within 3 months before signing the ICF and have been determined by researchers to significantly affect body weight and blood sugar.
  • 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 meet the following criteria:
  • Alanine aminotransferase >1.5x upper limit of normal (ULN), or ASpartate aminotransferase >1.5x ULN, alkaline phosphatase >1.5x ULN, or total bilirubin >1.5x ULN (subjects with Gilbert's syndrome can participate in this study if direct bilirubin ≤ULN);
  • calcitonin ≥50 ng/L;
  • Blood amylase or lipase >ULN;
  • Thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L;
  • Hemoglobin a1C (HbA1c) ≥6.0%; Fasting blood glucose ≥6.1 mmol/L or < 3.9 mmol/L; Or OGTT 2 h blood glucose ≥7.8 mmol/L;
  • eGFR < 60 mL/min/1.73m2;
  • Male QTcF>450 ms, female QTcF>470 ms
  • People tested positive for infectious diseases 12 Habitual smokers, alcoholics and drug abusers;
  • 13. Pregnant or lactating women 14. Blood donors within 3 months prior to randomization 15. In the Investigator's opinion, the subject is not suitable to participate in any other circumstances of the trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HDM1005 After a Single Subcutaneous Dose in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase Ia clinical study. It is aimed to evaluate the safety, tolerability, PK and PD characteristics of HDM1005 injection in healthy adult subjects.

Read the detailed description

In this study, 7 dose cohorts will be set up, with 10 subjects in each cohort, and subjects in each cohort will be randomized in a 4:1 ratio to receive HDM1005 injection or placebo via subcutaneous injection. Proposed dose cohorts include: Cohort 1 , Cohort 2 , Cohort 3 , Cohort 4, Cohort 5 , Cohort 6 , and Cohort 7. Scientific review committee (SRC) will be established to review the data in a blinded manner to confirm whether to proceed with the next cohort and determine the dose for the next cohort according to both protocol and data obtained from previous cohorts. Administration of higher dose cohorts will only be allowed when the safety and tolerability of the lower dose cohorts have been established and are acceptable. SRC composes representatives from the Sponsor (including but not limited to medical responsible, statistician, clinical pharmacologist) and investigator(s). External consultant may be invited as SRC member per specific scientific question.

Being tested
HDM1005 injection or placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HDM1005 injection or placeboDrug

    HDM1005 injection or placebo isubcutaneous injection once

Study groups in NCT06640647
Study groupRoleWhat they receive
HDM1005 injection dose level 1ExperimentalHDM1005 injection or placebo dose level 1 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 2ExperimentalHDM1005 injection or placebo dose level 2 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 3ExperimentalHDM1005 injection or placebo dose level 3 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 4ExperimentalHDM1005 injection or placebo dose level 4 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 5ExperimentalHDM1005 injection or placebo dose level 5 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 6ExperimentalHDM1005 injection or placebo dose level 6 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 7ExperimentalHDM1005 injection or placebo dose level 7 once subcutaneous injection
Receives: Drug: HDM1005 injection or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Outcomes

    The incidence, severity, and causality of adverse events (AE) and serious adverse events (SAEs) occurring during treatment, resulting in early termination of TEAEs, resulting in death of TEAEs; etc.

    Measured: Signing informed until day 29

Secondary outcomes (2)

  1. PK Outcomes

    PK parameters include, but are not limited to Area under the plasma concentration versus time curve (AUC)

    Measured: 0-672 hour(s)

  2. PD Outcomes

    Changes in body weight, body mass index (BMI), fasting glucose, fasting insulin, fasting C-peptide, blood lipids compared to baseline

    Measured: Baseline to day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start19 Mar 2024
  3. Primary completion6 Aug 2024
  4. Study completion26 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06640647
Sponsor's protocol ID
HDM1005-101
Status last verified
Oct 2024
First submitted
31 May 2024
Last updated
16 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Obesity and Overweight, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcomes (time frame: Signing informed until day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06640647.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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