Efficacy and SafetyPhase 2NCT06194188
A Phase 2 Clinical Study of CU-20401
A Phase 2 study testing Subcutaneous injection of CU-20401 in people with Efficacy and Safety, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Subcutaneous injection of CU-20401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2023to 2 Sep 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully understand the study contents, study process and possible adverse reactions, be able to complete the study in accordance with the protocol requirements, have reasonable expectations for the injection effect, and voluntarily sign the informed consent form;
- Men or women aged 18 to 65 years (including boundary values) at the time of signing the ICF;
- Body mass index (BMI) between 17 and 40 (kg/m2) at screening and baseline (including cut-off);
- At screening and baseline, the investigator rated moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS) , i.e., those with a score of 2 to 3 points; and the subject-reported Submental Fat Rating Scale (PR-SMFRS)rated the amount of submental fat as moderate/large/very large, i.e., those with a score of 2 to 4;
- Subjects of childbearing potential (including males and females) have no pregnancy plans and voluntarily take effective contraceptive measures at screening and throughout the trial, and have no sperm or egg donation plans.
Who cannot join
- Subjects who have received prior surgery, liposuction therapy, or injection of lipolytic drugs similar to the investigational drug (e.g., phosphatidylcholine, etc.) at the submental site;
- Those who have received biomaterial fillings (e.g., hyaluronic acid, collagen, etc.) within 24 months prior to screening and at the neck or submental site before baseline;
- Those who have received botulinum toxin injection within 3 months prior to screening and at the neck or submental site prior to baseline, or have received noninvasive skin tightening therapy;
- Planned to undergo cosmetic procedures at the submental site during the study, including, but not limited to, dermal filling, surgical wrinkle removal, photoelectric therapy, water light needles, microneedles, chemical exfoliation, or scar removal surgery, etc.;
- Enlargement of the submental area due to other causes of excess non-submental fat accumulation (e.g., goiter, lymphadenopathy, Madelong's disease, platysma protrusion at rest, etc.) or affect the investigator's assessment of submental fat;
- Those with obvious scars, infections, cancerous or precancerous lesions and/or unresolved wounds, retrognathia, etc. in the chin and neck position, which may affect the evaluation results as assessed by the investigator;
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- According to the investigator's judgment, submental fat dissolution can cause submental skin relaxation (SMSLG) to be Grade 4 or have other anatomic features (e.g., bulging fat under the platysma, extreme skin relaxation of the neck or submental area, protrusion of the platysma band), resulting in unacceptable cosmetic results;
- Subjects with a pre-existing tendency to scar hyperplasia or keloid may affect the efficacy assessment or subject safety after treatment as judged by the investigator;
- Subjects with symptoms or associated diseases of dysphagia at screening and baseline;
- Abnormal clinical laboratory tests (AST or ALT values above twice the upper limit of normal; serum creatinine above 1.5 times the upper limit of normal; triglycerides above 2 times the upper limit of normal) at screening and baseline; or other laboratory tests, vital signs, physical examination, electrocardiogram test results are abnormal and clinically significant, and the investigator considers it inappropriate to participate in this study;
- Other acute or chronic diseases (including but not limited to cardiovascular and cerebrovascular, respiratory, endocrine, digestive, renal, liver, blood and lymphatic, immune, metabolic and skeletal, central nervous system or psychiatric disorders, etc.) at screening and baseline, which, as judged by the investigator, may increase the risk associated with the use of the investigational product, or may affect the interpretation of the study results, or fail to cooperate well with the study participant;
- Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, treponema pallidum antibody (TP-Ab) test positive at screening;
- Clotting test results (prothrombin time, activated partial thromboplastin time) within 4 weeks prior to dosing indicate any clinically significant bleeding tendency (patients receiving antiplatelet, anticoagulant, acetylsalicylic acid therapy may be enrolled after a 7-day washout period);
- Those who have used topical medications (e.g., glucocorticoids, tretinoin ointment) within 4 weeks prior to screening and in the prebaseline submental area, or are expected to require use in the submental area during the course of the study (up to 12 weeks after completion of injection);
- Plan any surgery during the trial that may result in significant weight change (≥ 10%) or take any medication that may result in significant weight change (≥ 10%) (e.g. systemic corticosteroids, bariatric medications, bariatric surgery);
- Donation of blood or massive blood loss (≥ 400 mL) within 3 months prior to screening and prior to baseline;
- History of needle sickness and blood sickness;
- History of drug abuse within 6 months prior to screening and prior to baseline, or drug use within 3 months prior to screening and prior to baseline;
- Allergic constitution, or history of allergy to collagenase or components of the study drug or its excipients;
- Received collagenase treatment within 6 months prior to screening and prior to baseline;
- Those who have participated in any drug or medical device clinical trials within 3 months before screening and before baseline or within 1 month before screening and before baseline;
- Lactating and pregnant women;
- Those who cannot undergo magnetic resonance imaging (MRI) (e.g., with a pacemaker/electronic stimulator, an insulin pump, a cochlear implant, or stainless steel metal implanted in the body, etc.);
- Other conditions judged by the investigator to be inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of CU-20401 for Injection in Moderate to Severe Contour Protuberance or Excessive Enrichment Due to Submental Fat (SMF) Accumulation
This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.
Read the detailed description
Eligible subjects were randomized in a 1: 1: 1 ratio to CU-20401 low dose group (0.06 mg/dose), CU-20401 high dose group (0.08 mg/dose), or placebo group using the severity of baseline clinician-reported SMF accumulation (score 2 or 3) as a stratification factor, and received a single subcutaneous injection of this group in the submental fat region on D1; return to the hospital for efficacy assessment on D29, D57, D85 or at early withdrawal; return to the hospital for safety assessment on D1, D8, D15, D29, D57, D85 or early withdrawal; immunogenicity samples were collected on D1, D8, D15, D29, D57, D85, or at early withdrawal (the study design is shown in the figure below).
- Conditions
- Efficacy and Safety
- Being tested
- Subcutaneous injection of CU-20401
- Keywords
- immunogenicity, SMF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous injection of CU-20401Drug
Also called cu-20401
Reconstitute the product with 0.9% sodium chloride solution for injection, respectively, before use, for a single subcutaneous injection in the submental fat area.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Group | Experimental | 0.06mg/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation Receives: Drug: Subcutaneous injection of CU-20401 |
| High Dose Group | Experimental | 0.08 /ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation Receives: Drug: Subcutaneous injection of CU-20401 |
| Placebo group | Placebo comparator | 0/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation Receives: Drug: Subcutaneous injection of CU-20401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in both CR-SMFRS score and PR-SMFRS score at the same time
at least 1 point change in both clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score 爱at the same time.
CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few，4=a lot
Measured: Day 29
Secondary outcomes (9)
Proportion of subjects with at least 1 point change in CR-SMFRS score and PR-SMFRS score
Proportion of subjects with at least 1 point change in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score.
CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few，4=a lot
Measured: Day 57/ Day 85
Proportion of subjects with at least 2 points change in CR-SMFRS score and PR-SMFRS score
Proportion of subjects with at least 2 points change in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score.
CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few，4=a lot
Measured: Day 29/Day 57/Day 85
change from baseline in CR-SMFRS score
change from baseline in clinician-reported Submental Fat Rating Scale (CR-SMFRS) score，0=None,1=Minor,2=Moderate,3=Serious,4=very severe
Measured: Day 29/Day 57/Day 85
change from baseline in PR-SMFRS score
change from baseline insubject-reported Submental Fat Rating Scale (PR-SMFRS) score. ,0=None,1=very little,2=a little,3=a few,4=a lot
Measured: Day 29/Day 57/Day 85
Change from baseline in the total score of PR-SMFIS
Change from baseline in the total score of Submental Fat Impact Scale (PR-SMFIS) ,1=euphoria in the subject's mood ,2=distress,3=cares about，4=embarrassed about,5= look old,6=look overweight
Measured: Day 29/Day 57/Day 85
Proportion of subjects with at least a 10% reduction from baseline in submental fat volume using MRI
Proportion of subjects with at least a 10% reduction from baseline in submental fat volume using MRI
Measured: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat volume
MRI was used to examine the change from baseline in submental fat volume
Measured: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat thickness
MRI was used to examine the change from baseline in submental fat thickness
Measured: Day 29/Day 85
Change from baseline in Submental Skin Relaxity Scale (SMSLG)
Change from baseline in SMSLG score,1=None，2=Minor，3=Moderate，4=Serious
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start20 Dec 2023
- Primary completion2 Sep 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- byron Zhu, MD, Study chair, CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194188
- Sponsor's protocol ID
- CU-20401-203
- Status last verified
- Jan 2025
- First submitted
- 30 Nov 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of CU-20401 for Injection in Moderate to Severe Contour Protuberance or Excessive Enrichment Due to Submental Fat (SMF) Accumulation
- ClinicalTrials.gov ID
- NCT06194188
- Acronym / sponsor ID
- CU-20401-203
- Conditions
- Efficacy and Safety
- Keywords
- immunogenicity, SMF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 8 Jan 2024 (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.
This is a randomized, double-blind, placebo-controlled Phase Ⅱ clinical study to evaluate the efficacy, safety, and immunogenicity of CU-20401 for Injection in a population with moderate to severe contour elevation or over-fullness due to SMF accumulation.
Detailed description
Eligible subjects were randomized in a 1: 1: 1 ratio to CU-20401 low dose group (0.06 mg/dose), CU-20401 high dose group (0.08 mg/dose), or placebo group using the severity of baseline clinician-reported SMF accumulation (score 2 or 3) as a stratification factor, and received a single subcutaneous injection of this group in the submental fat region on D1; return to the hospital for efficacy assessment on D29, D57, D85 or at early withdrawal; return to the hospital for safety assessment on D1, D8, D15, D29, D57, D85 or early withdrawal; immunogenicity samples were collected on D1, D8, D15, D29, D57, D85, or at early withdrawal (the study design is shown in the figure below).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Group | Experimental | Drug: Subcutaneous injection of CU-204010.06mg/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation |
| High Dose Group | Experimental | Drug: Subcutaneous injection of CU-204010.08 /ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation |
| Placebo group | Placebo comparator | Drug: Subcutaneous injection of CU-204010/ml/dose, the number of doses administered (no more than 36 doses) will be determined after the area has been assessed by the investigator based on the subject's submental fat accumulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fully understand the study contents, study process and possible adverse reactions, be able to complete the study in accordance with the protocol requirements, have reasonable expectations for the injection effect, and voluntarily sign the informed consent form;
- Men or women aged 18 to 65 years (including boundary values) at the time of signing the ICF;
- Body mass index (BMI) between 17 and 40 (kg/m2) at screening and baseline (including cut-off);
- At screening and baseline, the investigator rated moderate to severe submental outline protrusion due to submental fat accumulation according to the clinician-reported Submental Fat Rating Scale (CR-SMFRS) , i.e., those with a score of 2 to 3 points; and the subject-reported Submental Fat Rating Scale (PR-SMFRS)rated the amount of submental fat as moderate/large/very large, i.e., those with a score of 2 to 4;
- Subjects of childbearing potential (including males and females) have no pregnancy plans and voluntarily take effective contraceptive measures at screening and throughout the trial, and have no sperm or egg donation plans.
Key exclusion criteria (24 listed)
- Subjects who have received prior surgery, liposuction therapy, or injection of lipolytic drugs similar to the investigational drug (e.g., phosphatidylcholine, etc.) at the submental site;
- Those who have received biomaterial fillings (e.g., hyaluronic acid, collagen, etc.) within 24 months prior to screening and at the neck or submental site before baseline;
- Those who have received botulinum toxin injection within 3 months prior to screening and at the neck or submental site prior to baseline, or have received noninvasive skin tightening therapy;
- Planned to undergo cosmetic procedures at the submental site during the study, including, but not limited to, dermal filling, surgical wrinkle removal, photoelectric therapy, water light needles, microneedles, chemical exfoliation, or scar removal surgery, etc.;
- Enlargement of the submental area due to other causes of excess non-submental fat accumulation (e.g., goiter, lymphadenopathy, Madelong's disease, platysma protrusion at rest, etc.) or affect the investigator's assessment of submental fat;
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 |
|---|---|---|
| Subcutaneous injection of CU-20401Also: cu-20401Reconstitute the product with 0.9% sodium chloride solution for injection, respectively, before use, for a single subcutaneous injection in the submental fat area. | Drug | High Dose Group, Low Dose Group, Placebo group |
Primary outcome
change in both CR-SMFRS score and PR-SMFRS score at the same time
Time frame: Day 29
at least 1 point change in both clinician-reported Submental Fat Rating Scale (CR-SMFRS) score and subject-reported Submental Fat Rating Scale (PR-SMFRS) score 爱at the same time. CR-SMFRS score ,0=None,1=Minor,2=Moderate,3=Serious,4=very severe. PR-SMFRS score,0=None,1=very little,2=a little,3=a few，4=a lot
9 secondary outcomes
Proportion of subjects with at least 1 point change in CR-SMFRS score and PR-SMFRS score
Time frame: Day 57/ Day 85
Proportion of subjects with at least 2 points change in CR-SMFRS score and PR-SMFRS score
Time frame: Day 29/Day 57/Day 85
change from baseline in CR-SMFRS score
Time frame: Day 29/Day 57/Day 85
change from baseline in PR-SMFRS score
Time frame: Day 29/Day 57/Day 85
Change from baseline in the total score of PR-SMFIS
Time frame: Day 29/Day 57/Day 85
Proportion of subjects with at least a 10% reduction from baseline in submental fat volume using MRI
Time frame: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat volume
Time frame: Day 29/Day 85
MRI was used to examine the change from baseline in submental fat thickness
Time frame: Day 29/Day 85
Change from baseline in Submental Skin Relaxity Scale (SMSLG)
Time frame: Day 85
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 22 Jan 2025.
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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.
byron Zhu, MD study chair
CMO
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 Subcutaneous injection of CU-20401 in people with Efficacy and Safety, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
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 24 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 22 Jan 2025. 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 China. 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 in both CR-SMFRS score and PR-SMFRS score at the same time (time frame: Day 29). 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 22 Jan 2025.