RecruitingPhase 1NCT06756490

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

Sponsor

Sichuan Huiyu Pharmaceutical Co., Ltd

Enrollment

30 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

Moderate or Severe Submental Fullness

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new injectable treatment (HY-2003) designed to reduce stubborn fat under the chin (the "double chin" area) to see if it is safe and effective in adults. **You may be eligible if...** - You are between 18 and 65 years old - You have moderate to severe fat buildup under your chin as rated by a doctor - Your weight has been stable for at least 6 months - You have no plans to become pregnant and will use effective contraception during and for 6 months after the trial **You may NOT be eligible if...** - You have had prior surgery, liposuction, or fat-dissolving injections in the chin area - You have allergies to deoxycholic acid or local anesthetics (like lidocaine) - Your BMI is below 17 or above 40 - You take blood thinners like aspirin, warfarin, or NSAIDs - You smoke more than 5 cigarettes per day - You are pregnant or breastfeeding - You have infections, skin diseases, or keloid scarring in the neck area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHY-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.

DRUGHY-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.

DRUGHY-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.

Locations(2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

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NCT06756490