ObesityPhase 2NCT02075281
Effect of LAPS-Exendin on Body Weight in Obese Population
A Phase 2 study testing HM11260C in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- 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
- 297 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- Phase
- Phase 2
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion Criteria:
- Age: 18 years to 65 years
- Genders: male and female
- healthy obese population
- non-diabetes
- stable body weight for at least 3 months prior to screening
- Exclusion Criteria
- Pregnant or nursing (lactating) women
- Drug-induced obesity
- Diabetes mellitus (type 1, 2, and other)
- Previous surgical treatment for obesity
- Any known history of severe gastrointestinal (GI) disease or intolerance
- Known history of pancreatitis with presence of raised serum amylase and lipase
- History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes
The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.
Read the detailed description
Phase 2 study
- 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.
HM11260CBiological
Glucagon-like peptide-1 analogue
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| HM11260C | Experimental | HM11260C 4 mg weekly sc injection Receives: Biological: HM11260C |
| Placebo | Placebo comparator | Placebo weekly sc injection Receives: Biological: Placebo |
| HM11260C 6 mg/week | Experimental | HM11260C 6 mg weekly sc injection Receives: Biological: HM11260C |
| HM11260C 6 mg/biweekly | Experimental | HM11260C 6 mg biweekly sc injection Receives: Biological: HM11260C |
| HM11260C 8 mg/biweekly | Experimental | HM11260C 8 mg biweekly sc injection Receives: Biological: HM11260C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at 20 weeks
Measured: 20 weeks from baseline
Secondary outcomes (3)
Number of participants with adverse event
Measured: during 20 weeks of treatment and follow-up period
Change from baseline in HbA1c and fasting plasma glucose level at 20 week
Measured: 20 weeks from baseline
Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week
Cholesterol level, LDL-C level
Measured: 20 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionFeb 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanmi pharmaceuticals Hanmi pharmaceuticals, Principal investigator, Hanmi pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075281
- Sponsor's protocol ID
- HM-EXC-205
- Status last verified
- Feb 2016
- First submitted
- 25 Feb 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes
- ClinicalTrials.gov ID
- NCT02075281
- Acronym / sponsor ID
- HM-EXC-205
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Mar 2014 (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 purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.
Detailed description
Phase 2 study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HM11260C | Experimental | Biological: HM11260CHM11260C 4 mg weekly sc injection |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo weekly sc injection |
| HM11260C 6 mg/week | Experimental | Biological: HM11260CHM11260C 6 mg weekly sc injection |
| HM11260C 6 mg/biweekly | Experimental | Biological: HM11260CHM11260C 6 mg biweekly sc injection |
| HM11260C 8 mg/biweekly | Experimental | Biological: HM11260CHM11260C 8 mg biweekly sc injection |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| HM11260CGlucagon-like peptide-1 analogue | Biological | HM11260C, HM11260C 6 mg/biweekly, HM11260C 6 mg/week, HM11260C 8 mg/biweekly |
| Placebo | Biological | Placebo |
Primary outcome
Change from baseline in body weight at 20 weeks
Time frame: 20 weeks from baseline
3 secondary outcomes
Number of participants with adverse event
Time frame: during 20 weeks of treatment and follow-up period
Change from baseline in HbA1c and fasting plasma glucose level at 20 week
Time frame: 20 weeks from baseline
Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week
Time frame: 20 weeks from baseline
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 9 Aug 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.
Hanmi pharmaceuticals Hanmi pharmaceuticals principal investigator
Hanmi pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HM11260C in people with Obesity, run by Hanmi Pharmaceutical Company Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Aug 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in body weight at 20 weeks (time frame: 20 weeks from baseline). 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 9 Aug 2016.