A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation

NCT06756490 | Recruiting Phase 1

• 1 other identifier: HY-2003-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• The occurrence of all adverse events; The occurrence of adverse events at the injection site; Laboratory tests, vital signs, physical examinations, 12-lead electrocardiograms.

  During the intervention

• Pain scores evaluated by the Visual Analogue Scale (VAS，0~10mm，the longer the length means a worse outcome）

  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）

  Four weeks and twelve weeks after the last treatment.

Study Arms (3)

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

Interventions

HY-2003 (5 mg/ml) and placebo DRUG

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.

Group B - Subjects will be randomly assigned to two subgroups

HY-2003 (10 mg/ml), BELKYRA and placebo DRUG

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.

Group A - Subjects will be randomly assigned to three subgroups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Sichuan Huiyu Pharmaceutical Co., Ltd: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chun Wan

CONTACT

028-86021875; chun.wan3717@huiyupharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 3, 2025
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)