Moderate or Severe Submental FullnessPhase 1NCT06756490
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
A Phase 1 study of Moderate or Severe Submental Fullness, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate or Severe Submental Fullness
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 26 Dec 2024to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 requirements of the trial, and signed the informed consent form voluntarily;
- The subjects should have good compliance, are able to fully understand this clinical trial, have reasonable expectations for the injection effects, and can abide by the research procedures until the end of the clinical trial.
- Aged 18 to 65 years (including boundary values), male or female.
- 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.
- Sufficient submental fat to allow for safe subcutaneous fat layer injections (at least 25 injections can be completed), as judged by the investigator.
- Stable body weight for at least 6 months prior to Screening.
- Vital sign examinations, physical examinations, clinical laboratory examinations (blood routine, urine routine, blood biochemistry, infectious disease screening, coagulation function, pregnancy test (for females), drug screening, etc.), and 12-lead electrocardiogram examinations, with the results showing no abnormalities or having abnormalities but judged by the researcher as being of no clinical significance.
- Subjects had no pregnancy plans and voluntarily take effective contraceptive measures during the screening period and within 6 months after the last dose, and have no sperm or egg donation plans.
Who cannot join
- Subjects who have previously undergone surgical operations, liposuction treatments in the submental area that may affect the implementation and/or evaluation of the study, or have been injected with lipolytic drugs similar to the study drugs (for example, phosphatidylcholine, etc.).
- Subjects who have had previous allergic reactions to deoxycholic acid or other components of the investigational drug.
- History of hypersensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine, etc.).
- Subjects with a history of prior surgery in the chin or neck region; or significant submental scarring, infection, cancerous or precancerous lesions, and/or unhealed wounds, mandibular retrusion (a mandibular retrusion malocclusion caused by mandibular hypoplasia or congenital absence of lower anterior teeth and lateral pterygoid insufficiency) that could affect the evaluation results as assessed by the investigator.
- Subjects with chin and neck skin diseases, or with a keloid-forming tendency (with a previous tendency of scar hyperplasia or keloid), which may affect the efficacy evaluation or subject safety as judged by the investigator.
- Subjects who have received previous lipolytic therapy with poor efficacy or serious adverse reactions.
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- Platissimus muscle protrusion at rest, as judged by the investigator, impacts assessment of submental fat status.
- Including but not limited to Madelung's disease (benign symmetric lipomatosis) which leads to an increase in local fat in the neck area and needs to be excluded as judged by the investigator.
- Body Mass Index (BMI) less than 17 or greater than 40 kg/m2 (excluding borderline) at screening.
- Current or past dysphagia.
- Subjects with very severe laxity of the submental skin as judged by the investigator.
- Enlargement of the submental area was found to be due to other causes rather than local excessive submental fat accumulation.
- Subjects who have used drugs that can prolong the clotting time (for example, aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within 2 weeks before screening, or who need to take any drugs with anticoagulant functions (including but not limited to warfarin, heparin) during the trial.
- Subjects who have used topical drugs (such as glucocorticoids, tretinoin ointment) on the submental skin within 1 month before screening, or who are expected to need to use these drugs on the submental area during the research process (until 12 weeks after the completion of the last injection).
- Subjects who have donated blood (including blood components) or suffered from massive blood loss (≥200 mL) within 3 months before screening.
- Subjects who smoked more than 5 cigarettes per day within 3 months before screening, or who were unable to stop using any tobacco products during the PK blood sampling period.
- Subjects who consumed more than 14 units of alcohol per week within 3 months before screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or who were unable to abstain from alcohol during the PK blood sampling period.
- Subjects who consumed any food or beverage containing caffeine or that can produce caffeine after metabolism (such as coffee, tea, chocolate) within 48 hours before drug administration; or those who did not agree to refrain from consuming such food or beverage during the PK blood sampling period.
- Subjects who participated in any other drug clinical trials and received drug treatment within 3 months before screening.
- Subjects with a history of drug abuse within 6 months before screening or who used drugs within 3 months before screening.
- Subjects who received ultrasonic scalpel, radiofrequency, laser surgery, chemical peeling or skin fillers (such as hyaluronic acid) treatment for the neck or submental area within 12 months before screening, or who received botulinum toxin injection treatment for the neck or submental area within 6 months before screening; or who received non-invasive skin tightening treatment within 6 months before screening.
- According to the researcher's judgment, the dissolution of submental fat would cause submental skin laxity or have other anatomical features (for example, protrusion of the subplatysmal fat, skin laxity in the neck or chin area, protrusion of the platysma band), resulting in an unacceptable cosmetic effect.
- At the time of enrollment screening, the results of coagulation function tests, including prothrombin time (PT) and activated partial thromboplastin time (APTT), showed bleeding abnormalities of clinical significance.
- Subjects who cannot tolerate venipuncture, have a history of fainting due to needles or blood, or have significant abnormal clinical manifestations.
- Subjects with diseases that require exclusion due to significant abnormal clinical manifestations, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, skeletal system and other systems.
- Subjects suffering from any diseases that may interfere with the safety assessment of the trial or affect the normal conduct of the clinical trial by the subjects or the signing of the informed consent form.
- Subjects whose participation in the trial may increase their risks or who may have other severe, acute or chronic diseases that may interfere with the interpretation of the trial results and are judged by the researcher as not suitable for participating in the clinical trial.
- Subjects who plan to undergo any surgeries or take any drugs that may lead to significant changes in body weight (≥10%) during the study period (for example, systemic corticosteroids, weight-loss drugs, bariatric surgeries).
- Subjects with infectious diseases before screening, such as syphilis, AIDS, hepatitis B, etc.
- Female subjects with potential fertility who are pregnant, breastfeeding, planning to become pregnant or not taking reliable contraceptive measures, and who are unwilling to adopt reliable contraceptive methods (for example: transdermal patches, intrauterine devices/systems (IUD/IUS), oral/implanted or injected contraceptives, abstinence and vasectomy of their spouses) during the participation in the trial.
- Subjects with other comorbidities that may interfere with the research assessment only as judged by the researcher, or subjects who are considered by the researcher as facing greater risks due to participation in the study.
- Subjects judged by the researcher as not suitable for participating in this trial for other reasons.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Xiaojun Wang, pumchwxj@163.com
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Maoguo Shu, shumaoguo@163.com
About this study
Official title: A Prospective, Blinded (Evaluators and Subjects Blinded), Randomized Controlled Phase I Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Liposome-encapsulated Deoxycholic Acid for Injection (HY-2003) Administered by Subcutaneous Fat Layer Injection in the Subjects With Excessive Submental Fat Accumulation
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.
- Conditions
- Moderate or Severe Submental Fullness
- Being tested
- HY-2003 (10 mg/ml), BELKYRA and placebo, HY-2003 (5 mg/ml) and placebo
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY-2003 (10 mg/ml), BELKYRA and placeboDrug
Participants received HY-2003 (10 mg/ml), or BELKYRA, or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments.
HY-2003 (5 mg/ml) and placeboDrug
Participants received HY-2003 (5 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
HY-2003 (5 mg/ml) and placeboDrug
Participants received HY-2003 (10 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. It is possible to explore the maximum number of administrations exceeding six treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Subjects will be randomly assigned to three subgroups | Experimental | Not described Receives: Drug: HY-2003 (10 mg/ml), BELKYRA and placebo |
| Group B - Subjects will be randomly assigned to two subgroups | Experimental | Not described Receives: Drug: HY-2003 (5 mg/ml) and placebo |
| Group C - Subjects will be randomly assigned to two subgroups | Experimental | Not described Receives: Drug: HY-2003 (5 mg/ml) and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms.
Measured: During the intervention
Pain scores evaluated by the Visual Analogue Scale (VAS，0~10mm，the longer the length means a worse outcome）
Measured: During the intervention
The scores of submental skin laxity evaluated by the Submental Skin Laxity Grade (SMSLG, 0~4 points, the higher score means a worse outcome）
Measured: Four weeks and twelve weeks after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start26 Dec 2024
- Primary completion6 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate or Severe Submental FullnessStudies of the same condition, open and under way.
- More trials run by Sichuan Huiyu Pharmaceutical Co., LtdThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756490
- Sponsor's protocol ID
- HY-2003-101
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 9 Mar 2026
- Results posted
- 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 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Blinded (Evaluators and Subjects Blinded), Randomized Controlled Phase I Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Liposome-encapsulated Deoxycholic Acid for Injection (HY-2003) Administered by Subcutaneous Fat Layer Injection in the Subjects With Excessive Submental Fat Accumulation
- ClinicalTrials.gov ID
- NCT06756490
- Acronym / sponsor ID
- HY-2003-101
- Conditions
- Moderate or Severe Submental Fullness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital, First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 6 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Jan 2025 (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.
The main purpose of this study is to evaluate the safety of HY-2003 in subjects with moderate to severe submental fat accumulation at different doses and dosing frequencies in comparison with the positive control and placebo. The secondary objectives include: Evaluating the pharmacokinetic characteristics of HY-2003 after a single administration in humans and obtaining preliminary pharmacokinetic parameters; Evaluating the efficacy of HY-2003 under different doses and dosing frequencies, compared with the positive control and placebo, in the treatment of subjects with moderate to severe submental fat accumulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Subjects will be randomly assigned to three subgroups | Experimental | Drug: HY-2003 (10 mg/ml), BELKYRA and placebo |
| Group B - Subjects will be randomly assigned to two subgroups | Experimental | Drug: HY-2003 (5 mg/ml) and placebo |
| Group C - Subjects will be randomly assigned to two subgroups | Experimental | Drug: HY-2003 (5 mg/ml) and placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand the requirements of the trial, and signed the informed consent form voluntarily;
- The subjects should have good compliance, are able to fully understand this clinical trial, have reasonable expectations for the injection effects, and can abide by the research procedures until the end of the clinical trial.
- Aged 18 to 65 years (including boundary values), male or female.
- 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.
- Sufficient submental fat to allow for safe subcutaneous fat layer injections (at least 25 injections can be completed), as judged by the investigator.
Key exclusion criteria (32 listed)
- Subjects who have previously undergone surgical operations, liposuction treatments in the submental area that may affect the implementation and/or evaluation of the study, or have been injected with lipolytic drugs similar to the study drugs (for example, phosphatidylcholine, etc.).
- Subjects who have had previous allergic reactions to deoxycholic acid or other components of the investigational drug.
- History of hypersensitivity to topical or local anesthetics (e.g., lidocaine, benzocaine, procaine, etc.).
- Subjects with a history of prior surgery in the chin or neck region; or significant submental scarring, infection, cancerous or precancerous lesions, and/or unhealed wounds, mandibular retrusion (a mandibular retrusion malocclusion caused by mandibular hypoplasia or congenital absence of lower anterior teeth and lateral pterygoid insufficiency) that could affect the evaluation results as assessed by the investigator.
- Subjects with chin and neck skin diseases, or with a keloid-forming tendency (with a previous tendency of scar hyperplasia or keloid), which may affect the efficacy evaluation or subject safety as judged by the investigator.
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 |
|---|---|---|
| HY-2003 (10 mg/ml), BELKYRA and placeboParticipants received HY-2003 (10 mg/ml), or BELKYRA, or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. | Drug | Group A - Subjects will be randomly assigned to three subgroups |
| HY-2003 (5 mg/ml) and placeboParticipants received HY-2003 (5 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments. | Drug | Group B - Subjects will be randomly assigned to two subgroups |
| HY-2003 (5 mg/ml) and placeboParticipants received HY-2003 (10 mg/ml) or placebo administered up to 10 mL per treatment session at intervals of approximately 4 weeks for up to a maximum of 6 treatments. It is possible to explore the maximum number of administrations exceeding six treatment sessions. | Drug | Group C - Subjects will be randomly assigned to two subgroups |
Primary outcome
The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms.
Time frame: During the intervention
Pain scores evaluated by the Visual Analogue Scale (VAS，0~10mm，the longer the length means a worse outcome）
Time frame: During the intervention
The scores of submental skin laxity evaluated by the Submental Skin Laxity Grade (SMSLG, 0~4 points, the higher score means a worse outcome）
Time frame: Four weeks and twelve weeks after the last treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Moderate or Severe Submental Fullness, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 2 sites 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 8 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun Wan (028-86021875, chun.wan3717@huiyupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms. (time frame: During the intervention). The study lists 3 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 9 Mar 2026.