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New Weight-Loss injection HDM1005 tested in small early trial

NCT ID NCT06637020

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This early-phase trial tested a new drug called HDM1005 in 40 overweight or obese adults. Participants received either the drug or a placebo as a shot under the skin. The main goal was to check safety and how the body processes the drug, not yet to prove it works for weight loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HDM1005 injection
What this could lead to
If this drug proves safe and effective in larger trials, it could become a new option for weight management in people with overweight or obesity.
What could go wrong
This is a very early phase 1 study with only 40 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful weight loss in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

80 people

The number who actually took part.

Started

Jun 2024

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.