New obesity drug aims for major weight loss in phase 3 trial
NCT ID NCT06174779
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
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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 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: 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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