New Weight-Loss injection HDM1005 tested in small early trial
NCT ID NCT06637020
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 Hide 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.
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
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