Actively Recruiting
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
Led by Sichuan Huiyu Pharmaceutical Co., Ltd · Updated on 2026-03-09
30
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
Sponsors
S
Sichuan Huiyu Pharmaceutical Co., Ltd
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Study of HY-2003 in the Subjects With Excessive Submental Fat Accumulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form
- Able to comply with study procedures and expectations
- Aged 18 to 65 years, male or female
- Moderate to severe submental fat accumulation rated 2 to 3 on the clinician-reported scale
- Enough submental fat for safe injections (at least 25 injections possible)
- Stable body weight for at least 6 months before screening
- Normal or clinically insignificant abnormal results on vital signs, physical exams, lab tests, and ECG
- No pregnancy plans and agree to use effective contraception during the study and for 6 months after last dose
- No plans for sperm or egg donation during the study
You will not qualify if you...
- Previous surgery, liposuction, or fat-reducing injections in the submental area
- Allergic reactions to deoxycholic acid or study drug components
- Hypersensitivity to local anesthetics
- History of chin or neck surgery, significant scarring, infection, cancerous or precancerous lesions, or unhealed wounds in the area
- Skin diseases or keloid scarring tendencies affecting the chin or neck
- Previous lipolytic therapy with poor results or serious side effects
- Platysmus muscle protrusion affecting fat assessment
- Certain fat disorders like Madelung's disease
- Body Mass Index under 17 or over 40 kg/m2
- Current or past swallowing difficulties
- Very severe skin looseness under the chin
- Submental enlargement from causes other than fat accumulation
- Use of blood-thinning drugs within 2 weeks before screening or during the study
- Use of topical drugs on submental skin within 1 month before screening or expected use during the study
- Recent blood donation or major blood loss within 3 months
- Smoking more than 5 cigarettes daily within 3 months before screening
- Consuming more than 14 alcohol units weekly within 3 months before screening
- Consumption of caffeine-containing products within 48 hours before drug administration
- Participation in other drug trials with treatment within 3 months
- History of drug abuse within 6 months or drug use within 3 months
- Recent cosmetic treatments on chin or neck within 6 to 12 months
- Anatomical features that could cause unacceptable cosmetic results
- Abnormal blood clotting tests indicating bleeding issues
- History of fainting from needles or blood
- Serious diseases affecting nervous, cardiovascular, immune, kidney, liver, respiratory, metabolic, skeletal, or other systems
- Conditions interfering with safety assessments or study conduct
- Planned surgeries or drugs causing significant weight changes during the study
- Infectious diseases like syphilis, AIDS, hepatitis B
- Pregnancy, breastfeeding, or unwillingness to use reliable contraception
- Other health issues posing increased risks or interfering with study results
- Judged unsuitable for participation by the researcher due to any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
C
Chun Wan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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