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New weekly shot aims to shed pounds in obesity trial

NCT ID NCT07279194

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new drug called HDM1005, given as a weekly injection, to help people with obesity or overweight lose weight. It includes 825 Chinese adults who do not have diabetes. Participants receive either the drug or a placebo for 52 weeks, along with diet and exercise advice. The main goal is to see how much weight they lose after 40 weeks.

What this could mean

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

Active substance
HDM1005 (a weekly injection for weight loss)
What this could lead to
If successful, this could provide a new weekly injection option for significant weight loss in people with obesity or overweight.
What could go wrong
This is a Phase 3 trial, but results may not apply to non-Chinese populations. Side effects from the drug are possible, and weight regain may occur after stopping treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 825 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Male or female, aged ≥18 years at the time of signing informed consent. 2. BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain. 3. A self-reported change in body weight no more than 5% within 90 days before screening. 4. Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Have type 1 diabetes mellitus (T1DM) or T2DM. 2. Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit 1. 3. Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine. 4. Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening. 5. Use of hypoglycemic drugs within 3 months prior to screening. 6. History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history. 7. Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history. 8. PHQ questionnaire ≥ 15 points at screening or randomization. 9. Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past. 10. Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs). 11. History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening. 12. History of severe cardiovascular or cerebrovascular diseases within the past six months. 13. History of alcohol and drug abuse at screening. 14. The participant may be allergic to ingredients in the study drug or drugs of the same class. 15. Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study. 16. The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hoapital

    RECRUITING

    Shanghai, China

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