Treatment for Submental FatPhase 2SMFNCT03224117
Clinicial Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
A Phase 2 study testing DWJ211 and Normal saline in people with Treatment for Submental Fat, run by Daewoong Pharmaceutical Co. LTD. at 3 sites in South Korea.
Trial summary
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment for Submental Fat
- What is being tested?
- DWJ211 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 26 Oct 2017to 29 Jun 2018
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
- Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
- less than 35kg/m2 in body mass index on Visit1.
- subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
- subject who will agree with maintaining their body weight.
Who cannot join
- History of any intervention to treat SMF
- History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
- Evidence of any cause of enlargement in the submental area.
- history or current symptoms of dysphagia.
- a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chung-ang university hospital
Seoul
Konkuk university medical center
Seoul
Seoul Asan medical center
Seoul
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Finding Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
Read the detailed description
DWJ211
_ reduction of moderate or severe submental fat
- Conditions
- Treatment for Submental Fat
- Being tested
- DWJ211, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ211Drug
inject the Drug into submental fat via subcutaneous
Normal salineDrug
inject the Drug into submental fat via subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | SQ injection Receives: Drug: Normal saline |
| DWJ211_0.5% | Experimental | SQ injection with DWJ211 0.5% Receives: Drug: DWJ211 |
| DWJ211_1% | Experimental | SQ injection with DWJ211 1.0% Receives: Drug: DWJ211 |
| DWJ211_2% | Experimental | SQ injection with DWJ211 2.0% Receives: Drug: DWJ211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-grade response : PA-SMFRS
proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
Measured: 4 week after last treatment
2-grade response : SA-SMFRS
proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
Measured: 4 week after last treatment
1-grade response : PA-SMFRS
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
Measured: 4 week after last treatment
1-grade response : SA-SMFRS
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
Measured: 4 week after last treatment
Secondary outcomes (4)
MRI volume response rate
change rate of reduction in SMF volume
Measured: 4 week after last treatment
improvement: SA-SMFIS
improvement in the Subject reported submental fat impact scale overall score
Measured: 4 week after last treatment
obtained 5 score : SSS
proportion of subjects who have more than 5 score on the SSS(somewhat satisfied)
Measured: 4 week after last treatment
thickness response rate : caliper
change rate of reduction in SMF volume
Measured: 4 week after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start26 Oct 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment for Submental FatStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beom Joon Kim, MD, PhD, Study chair, Chung-Ang University HospitalYang-won Lee, MD, PhD, Principal investigator, Konkuk University Medical CenterChong-hyun Won, MD, PhD, Principal investigator, Seoul Asan medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224117
- Sponsor's protocol ID
- DW_DWJ211001
- Acronym
- SMF
- Status last verified
- Apr 2024
- First submitted
- 19 Jul 2017
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Finding Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
- ClinicalTrials.gov ID
- NCT03224117
- Acronym / sponsor ID
- SMF / DW_DWJ211001
- Conditions
- Treatment for Submental Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 21 Jul 2017 (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.
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
Detailed description
DWJ211
_ reduction of moderate or severe submental fat
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Normal salineSQ injection |
| DWJ211_0.5% | Experimental | Drug: DWJ211SQ injection with DWJ211 0.5% |
| DWJ211_1% | Experimental | Drug: DWJ211SQ injection with DWJ211 1.0% |
| DWJ211_2% | Experimental | Drug: DWJ211SQ injection with DWJ211 2.0% |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.
- Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
- less than 35kg/m2 in body mass index on Visit1.
- subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
- subject who will agree with maintaining their body weight.
Key exclusion criteria (5 listed)
- History of any intervention to treat SMF
- History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.
- Evidence of any cause of enlargement in the submental area.
- history or current symptoms of dysphagia.
- a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.
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 |
|---|---|---|
| DWJ211inject the Drug into submental fat via subcutaneous | Drug | DWJ211_0.5%, DWJ211_1%, DWJ211_2% |
| Normal salineinject the Drug into submental fat via subcutaneous | Drug | Placebo |
Primary outcome
2-grade response : PA-SMFRS
Time frame: 4 week after last treatment
proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
2-grade response : SA-SMFRS
Time frame: 4 week after last treatment
proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
1-grade response : PA-SMFRS
Time frame: 4 week after last treatment
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment
1-grade response : SA-SMFRS
Time frame: 4 week after last treatment
proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment
4 secondary outcomes
MRI volume response rate
Time frame: 4 week after last treatment
improvement: SA-SMFIS
Time frame: 4 week after last treatment
obtained 5 score : SSS
Time frame: 4 week after last treatment
thickness response rate : caliper
Time frame: 4 week after last treatment
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 4 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Beom Joon Kim, MD, PhD study chair
Chung-Ang University Hospital
Yang-won Lee, MD, PhD principal investigator
Konkuk University Medical Center
Chong-hyun Won, MD, PhD principal investigator
Seoul Asan medical center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWJ211 and Normal saline in people with Treatment for Submental Fat, run by Daewoong Pharmaceutical Co. LTD. at 3 sites 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 5 inclusion and 5 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
2-grade response : PA-SMFRS (time frame: 4 week after last treatment). The study lists 4 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 4 Apr 2024.