New obesity drug aims for major weight loss in phase 3 trial

NCT ID NCT06174779

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This phase 3 study tests an investigational drug called HM11260C for weight loss in adults with obesity who do not have diabetes. Participants must have a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with related health issues like high blood pressure. The trial compares the drug against a placebo to see how much weight people lose and how many achieve at least a 5% reduction in body weight.

What this could mean

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

Active substance
HM11260C
What this could lead to
If successful, this could provide a new medication option for significant weight loss in people with obesity.
What could go wrong
This is a phase 3 trial, but the drug may still fail to show sufficient benefit or cause side effects. Weight regain after stopping is possible.

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

448 people

The number who actually took part.

Started

Jan 2024

Finished

Mar 2026

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

19 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. Patients with following criteria : * BMI ≥ 30 kg/m2 or * 27 kg/m2 ≤ BMI \< 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease) 2. A person who have failed at least once to weight control using diet and exercise therapy before screening visit. Exclusion Criteria: 1. A person whose weight change exceeds 5kg within 3 months prior to screening visit. 2. Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %. 3. Administration of hypoglycemic agents. 4. Administration of medicines inducing weight gain. 5. Prader-Willi Syndrome or MC4R deficiency. 6. Cushing's Syndrome. 7. Administration of medicines for weight management. 8. A person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period. 9. Administration of Steroids for the systemic use. 10. Clinically significant gastric emptying abnormalities. 11. History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis. 12. History of acute or chronic pancreatitis. 13. A person who has the following clinical laboratory test results : * TSH \< 0.4 mIU/L or TSH \> 6 mIU/L * Calcitonin \> 100 ng/L * Amylase or Lipase \> 3 x UNL 14. Severe liver disease (AST or AST \> 3 x UNL or Total bilirubin \> 1.5 x UNL). 15. Severe renal disease ( eGFR \< 30mL/min/1.73m 2 ). 16. QTc \> 450 ms. 17. Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt. 18. PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness. 19. History of alcohol addiction or drug abuse. 20. History of malignant tumors. 21. History of severe heart disease or severe neurovascular disease. 22. Hypersensitivity to investigational products or multi-drug allergy. 23. Positive to pregnancy test, nursing mother, intention on pregnancy. 24. Considered by investigator as not appropriate to participate in the clinical study with other reason.

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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

  • Kangbuk samsung hospital

    Seoul, South Korea

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