NCT06756490

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sichuan Huiyu Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-12-26
• Primary completion: 2026-12-06
• Completion: 2027-05-31
• First posted: 2025-01-03
• Last updated: 2026-03-09

Locations

2 sites across 1 country: China