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

NCT06756490 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-09

No results posted yet for this study

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

Interventions

DRUG

HY-2003 (5 mg/ml) and placebo

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.

DRUG

HY-2003 (5 mg/ml) and placebo

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.

DRUG

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

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Sichuan Huiyu Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-26
Primary Completion
2026-12-06
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06756490 on ClinicalTrials.gov