ObesityPhase 3NCT06174779
A Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
A Phase 3 study testing HM11260C in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- HM11260C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jan 2024to 13 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- A person who have failed at least once to weight control using diet and exercise therapy before screening visit.
Who cannot join
- A person whose weight change exceeds 5kg within 3 months prior to screening visit.
- Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
- Administration of hypoglycemic agents.
- Administration of medicines inducing weight gain.
- Prader-Willi Syndrome or MC4R deficiency.
- Cushing's Syndrome.
Show all 27Show fewer
- Administration of medicines for weight management.
- 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.
- Administration of Steroids for the systemic use.
- Clinically significant gastric emptying abnormalities.
- History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
- History of acute or chronic pancreatitis.
- 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
- Severe liver disease (AST or AST > 3 x UNL or Total bilirubin > 1.5 x UNL).
- Severe renal disease ( eGFR < 30mL/min/1.73m 2 ).
- QTc > 450 ms.
- Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
- PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
- History of alcohol addiction or drug abuse.
- History of malignant tumors.
- History of severe heart disease or severe neurovascular disease.
- Hypersensitivity to investigational products or multi-drug allergy.
- Positive to pregnancy test, nursing mother, intention on pregnancy.
- Considered by investigator as not appropriate to participate in the clinical study with other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus
- Conditions
- Obesity
- Being tested
- HM11260C, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM11260CDrug
Test drug
PlaceboDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| HM11260C | Experimental | Weekly administration by subcutaneous injection Receives: Drug: HM11260C |
| Placebo | Placebo comparator | Weekly administration by subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change of body weight from baseline
Measured: baseline, 40 weeks
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Measured: baseline, 40 weeks
Secondary outcomes (10)
The percent change of body weight from baseline
Measured: baseline, 24 weeks, 64 weeks
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Measured: baseline, 24 weeks, 64 weeks
The proportion of subjects achieving body weight loss ≥ 10% from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of body weight from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of BMI from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of waist circumference from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of glucose metabolism parameters from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
The percentage change of lipid profile parameters from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of blood pressure from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Change of IWQoL-Lite-CT(Physical function domain) from baseline
Measured: baseline, 24 weeks, 40 weeks, 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start3 Jan 2024
- Primary completion14 Aug 2025
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174779
- Sponsor's protocol ID
- HM-EXC-301
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06174779
- Acronym / sponsor ID
- HM-EXC-301
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients without diabetes mellitus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HM11260C | Experimental | Drug: HM11260CWeekly administration by subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboWeekly administration by subcutaneous injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with following criteria :
- A person who have failed at least once to weight control using diet and exercise therapy before screening visit.
Key exclusion criteria (27 listed)
- A person whose weight change exceeds 5kg within 3 months prior to screening visit.
- Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
- Administration of hypoglycemic agents.
- Administration of medicines inducing weight gain.
- Prader-Willi Syndrome or MC4R deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM11260CTest drug | Drug | HM11260C |
| PlaceboPlacebo drug | Drug | Placebo |
Primary outcome
The percent change of body weight from baseline
Time frame: baseline, 40 weeks
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Time frame: baseline, 40 weeks
10 secondary outcomes
The percent change of body weight from baseline
Time frame: baseline, 24 weeks, 64 weeks
The proportion of subjects achieving body weight loss ≥ 5% from baseline
Time frame: baseline, 24 weeks, 64 weeks
The proportion of subjects achieving body weight loss ≥ 10% from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of body weight from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of BMI from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of waist circumference from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of glucose metabolism parameters from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
The percentage change of lipid profile parameters from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of blood pressure from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Change of IWQoL-Lite-CT(Physical function domain) from baseline
Time frame: baseline, 24 weeks, 40 weeks, 64 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HM11260C in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change of body weight from baseline (time frame: baseline, 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.