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Overweight and ObesityPhase 1NCT06637020

Phase Ib Clinical Study of HDM1005 Injection

A Phase 1 study of Overweight and Obesity, 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 study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study in overweight or obese subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HDM1005 injection in overweight or obese subjects. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and Obesity
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
21 Jun 2024to 24 Jun 2025
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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:
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

Other trials in China

About this study

Official title: 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

This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study in overweight or obese subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HDM1005 injection in overweight or obese subjects.

Read the detailed description

This study is designed to consist of two parts: Part 1 includes 4 dose cohorts, with 10 subjects in each cohort. Within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously. The proposed dose cohorts are as follows: cohort a (0.5 mg), cohort b (1.0 mg), cohort c (2.0 mg), cohort d (4.0 mg). Cohorts d will use a titration method to gradually reach the target dose. After obtaining safety and tolerability data for at least 14 days following multiple ascending dose (MAD) in the previous dose cohort, the dose to be administered and titration strategy for the next dose cohort are jointly determined by the investigator and the sponsor. Administration is allowed in the higher dose cohort only if the data from the lower dose cohort is indicative of safety. If necessary, the sponsor may continue to explore higher dose cohorts with the agreement of both the investigator and the sponsor. Following Part 1, Part 2 includes one 4 mg dose cohort (Cohort 1), enrolling 40 subjects who are randomized in a 3:1 ratio to receive either HDM1005 injection or placebo via subcutaneous injection, using a titration approach to gradually reach the target dose.

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

What participants receive

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

  • HDM1005 injection or placeboDrug

    Also called HDM1005

    In Part 1, within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

  • HDM1005 injection or placeboDrug

    In Part 2，subjects are randomized in a 3:1 ratio to receive either HDM1005 injection or placebo subcutaneously.

Study groups in NCT06637020
Study groupRoleWhat they receive
HDM1005 injection dose level 1（Part 1）ExperimentalHDM1005 injection or pleacebo dose level 1 qw subcutaneous injection, 4weeks
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 2 （Part 1）ExperimentalHDM1005 injection or pleacebo dose level 2 qw subcutaneous injection, 4weeks
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 3 （Part 1）ExperimentalHDM1005 injection or pleacebo dose level 3 qw subcutaneous injection, 4weeks
Receives: Drug: HDM1005 injection or placebo
HDM1005 injection dose level 4 （Part 1）ExperimentalHDM1005 injection or pleacebo dose level 3 qw subcutaneously administered once weekly, for 2 times; subsequently increased to dose level 4 once weekly for 2 times.
Receives: Drug: HDM1005 injection or placebo
Experimental: HDM1005 injection one dose level with stepwise titration from a lower dose (Part 2）ExperimentalHDM1005 injection or pleacebo 0.5 mg qw subcutaneously administered once weekly, for 2 times; subsequently increased to 1 mg once weekly for 2 times; subsequently increased to 2 mg once weekly for 4 times; subsequently increased to 3 mg once weekly for 4 times; finally increased to 4 mg once weekly for 4 times.
Receives: Drug: HDM1005 injection or placebo

What is being measured

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

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

    Safety Outcomes . The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) occurring during the study period; TEAEs leading to early study termination; TEAEs leading to death, etc.

    Measured: Signing informed until day 57

Secondary outcomes (1)

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

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

    Measured: Before the first dose to 672 hours after the last dose

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 start21 Jun 2024
  3. Primary completion28 Mar 2025
  4. Study completion24 Jun 2025

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06637020
Sponsor's protocol ID
HDM1005-102
Status last verified
Jul 2024
First submitted
31 May 2024
Last updated
24 Aug 2026
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 Overweight and Obesity, 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 22 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 24 Aug 2026. 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?

The incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Signing informed until day 57). 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 NCT06637020.

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 24 Aug 2026.

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