Actively Recruiting
A Preliminary Study to Explore the Efficacy of a GLP-1/FGF21 Dual Agonist (HEC88473) in Patients With Polycystic Ovary Syndrome (PCOS)
Led by Shanghai Zhongshan Hospital · Updated on 2026-05-29
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Polycystic ovary syndrome (PCOS) is a common hormonal and metabolic disorder affecting women of reproductive age. It features irregular or absent ovulation, high levels of male hormones, and polycystic ovaries, often accompanied by issues like insulin resistance and obesity. Researchers are studying a new drug called HEC88473, which acts on both the GLP-1 and FGF21 receptors, to see if it can improve PCOS symptoms and metabolic problems in women. The study evaluates HEC88473 given as a weekly injection starting at 15 mg for 3 weeks, then increasing to 30 mg for 3 weeks, and finally to 45 mg for 18 weeks if tolerated. This treatment aims to affect androgen metabolism and other PCOS-related factors. The trial is a Phase 2 study focusing on women with PCOS and includes a 24-week treatment period. Participants will be monitored regularly to assess changes in free androgen index, menstrual cycle frequency, ovarian features by ultrasound, hormone levels, insulin resistance, lipid profiles, body weight, waist circumference, and quality of life. Safety and adverse events will also be tracked throughout the 24 weeks. The study involves multiple follow-up visits to measure these outcomes and evaluate the drug's effects on PCOS symptoms and metabolism.
CONDITIONS
Brief Title
Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Female
- No plan for pregnancy from signing consent until 2 months after last dose
- Willingness to use approved contraceptive methods during the study period
- Meet at least two PCOS diagnostic criteria: irregular menstrual cycles, polycystic ovarian morphology confirmed by ultrasound, or hyperandrogenism (biochemical or clinical)
You will not qualify if you...
- Use of hormonal contraceptives within 2 months prior to screening
- History of acute or chronic pancreatitis or pancreatic injury
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B
- History of type 1 or type 2 diabetes mellitus
- Other endocrine disorders causing polycystic ovarian morphology
- Current use of medications affecting reproductive function or metabolism without required discontinuation periods
- History of bariatric surgery within past 12 months
- Treatment with GLP-1 receptor agonists within past 12 months
- Pregnancy or lactation
- Serious diseases of major organs or malignancy
- Any condition interfering with study evaluation or participant suitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive weekly subcutaneous injections of the GLP-1/FGF21 dual agonist starting at 15 mg with dose escalation to 30 mg and then 45 mg as tolerated over the course of treatment.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 201508
Actively Recruiting
Research Team
J
Jingjing JIANG, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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