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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.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are GLP-1/FGF21 dual agonist (HEC88473). The registry lists allocation as na. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age.
They plan to enroll about 30 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Preliminary Study to Explore the Efficacy of a GLP-1/FGF21 Dual Agonist (HEC88473) in Patients With Polycystic Ovary Syndrome (PCOS)
Primary outcome (registry wording): Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment
Who it is for (from inclusion criteria)
Ages 18 Years to 40 Years
Women only
Age between 18 and 40 years
Fulfillment of at least two of the diagnostic criteria for PCOS according to the 2023 International Guideline, including:
Irregular menstrual cycles:
1-3 years after menarche: cycle length \<21 days or \>45 days; ≥3 years after menarche to perimenopause: cycle length \<21 days or \>35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any cycle \>90 days;
Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter \<10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;
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
Presence of other endocrine disorders that may cause polycystic ovarian morphology, such as 21-hydroxylase deficiency, pituitary prolactinoma, hypothyroidism, or Cushing's syndrome
Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH agonists or antagonists, anti-androgens, and gonadotropins
Current use of other medications that may affect metabolism, with discontinuation less than 1 month prior to screening, including metformin, thiazolidinediones, and SGLT2 inhibitors
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07616037?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07616037?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.