Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS
ConditionPCOS (Polycystic Ovary Syndrome)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorShanghai Zhongshan Hospital
About this trial
Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age. It is characterized by oligo-ovulation or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. In addition, PCOS is frequently accompanied by multiple metabolic abnormalities, including insulin resistance, obesity, impaired glucose tolerance, and dyslipidemia. Clinical studies have demonstrated that treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) in women with PCOS results in significant weight reduction, decreased free testosterone levels, improvement in menstrual regularity, and increased clinical pregnancy rates. Fibroblast growth factor 21 (FGF21) has been shown to enhance insulin sensitivity, promote fatty acid oxidation, and improve lipid distribution.
HEC88473 is a novel long-acting dual agonist targeting both the glucagon-like peptide-1 (GLP-1) receptor and the fibroblast growth factor 21 (FGF21) receptor. This study is initiated to evaluate the clinical efficacy of HEC88473 in women with PCOS and to explore its potential as a new therapeutic option for the management of PCOS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 40 years.
Female.
No plan for pregnancy from the time of signing the informed consent until 2 months after the last dose of study drug, and willingness to use study-approved contraceptive methods during this period.
Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter <10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
GLP-1/FGF21 dual agonist (HEC88473)
DrugGLP-1/FGF21 dual agonist (HEC88473) will be administered by subcutaneous injection once weekly. The starting dose is 15 mg for 3 consecutive weeks. If well tolerated, the dose will be escalated to 30 mg for an additional 3 weeks, followed by further escalation to 45 mg for 18 weeks, provided tolerability is maintained.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: HEC88473 Treatment in Women With PCOSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
Longitudinal changes in free androgen index from baseline at each scheduled follow-up visit during the 24-week treatment period.
Time frame
Baseline to Week 24 (assessed at scheduled follow-up visits).Secondary outcomes
1
Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period
Comparison of the number of spontaneous menstrual cycles during the 24-week intervention period with those during the 24-week period prior to treatment initiation.
Time frame
24 weeks before treatment initiation to 24 weeks after treatment initiation.2
Change From Baseline in Bilateral Antral Follicle Count (Diameter <10 mm) at Week 24
Change from baseline in the total number of antral follicles with a diameter \<10 mm in both ovaries after 24 weeks of treatment.
Time frame
Baseline to Week 24.3
Change From Baseline in Bilateral Ovarian Volume at Week 24
Change from baseline in the total ovarian volume of both ovaries after 24 weeks of treatment.
Time frame
Baseline to Week 24.4
Change From Baseline in Serum AMH at Week 24
Change from baseline in serum levels of anti-Müllerian hormone (AMH) after 24 weeks of treatment.
Time frame
Baseline to Week 24.Sponsors and contacts
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Source ClinicalTrials.gov