Abdominal Obesity Metabolic SyndromePhase 3NCT01872182
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
A Phase 3 study testing ALS-L1023 in people with Abdominal Obesity Metabolic Syndrome, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Abdominal Obesity Metabolic Syndrome
- What is being tested?
- ALS-L1023
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Jan 2015
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 and 64 years(Both genders)
- more than 2 among components of the metabolic syndrome
- Triglyceride >= 150mg/dL
- HDL-D: Women < 50mg/dL or Men < 40mg/dL
- Hypertension: Systolic blood pressure >= 130mmHg or Diastolic blood pressure >= 85mmHg
- Hyperglycemia: fasting plasma glucose >= 100 mg/dL
- Informed consent awarding
Who cannot join
- Alcohol or any drug abuse
- Any investigational medication during the preceding 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.
- Conditions
- Abdominal Obesity Metabolic Syndrome
- Being tested
- ALS-L1023, placebo
- Medical subject headings
- Abdominal obesity metabolic syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALS-L1023Drug
daily twice for 12 weeks
placeboDrug
daily twice for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | ALS-L1023 300mg in two tablets Receives: Drug: ALS-L1023 |
| Comparator arm | Placebo comparator | placebo in two tablets Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline to 12 week in visceral fat area measured by CT
Measured: baseline and 12 week
Secondary outcomes (3)
improvement of metabolic profile
Measured: baseline and 12 week
change of insulin resistance
Measured: baseline and 12 week
change of BMI
Measured: baseline and 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Obesity Metabolic SyndromeStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hye Soon Park, M.D., Ph.D., M.P.H., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872182
- Sponsor's protocol ID
- HM-MELS-301
- Status last verified
- Oct 2016
- First submitted
- 30 May 2013
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01872182
- Acronym / sponsor ID
- HM-MELS-301
- Conditions
- Abdominal Obesity Metabolic Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Jun 2013 (estimated)
- 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.
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Drug: ALS-L1023ALS-L1023 300mg in two tablets |
| Comparator arm | Placebo comparator | Drug: placeboplacebo in two tablets |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 20 and 64 years(Both genders)
- more than 2 among components of the metabolic syndrome
- Informed consent awarding
Key exclusion criteria (2 listed)
- Alcohol or any drug abuse
- Any investigational medication during the preceding 3 months
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 |
|---|---|---|
| ALS-L1023daily twice for 12 weeks | Drug | Test arm |
| placebodaily twice for 12 weeks | Drug | Comparator arm |
Primary outcome
Percent change from baseline to 12 week in visceral fat area measured by CT
Time frame: baseline and 12 week
3 secondary outcomes
improvement of metabolic profile
Time frame: baseline and 12 week
change of insulin resistance
Time frame: baseline and 12 week
change of BMI
Time frame: baseline and 12 week
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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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.
Hye Soon Park, M.D., Ph.D., M.P.H. principal investigator
Asan Medical Center
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 ALS-L1023 in people with Abdominal Obesity Metabolic Syndrome, 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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Oct 2016. 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 was stopped early. Results are not available in the source record.
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?
Percent change from baseline to 12 week in visceral fat area measured by CT (time frame: baseline and 12 week). 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 11 Oct 2016.