BridgeMD
Tests treatment safety and results for PCOS (Polycystic Ovary Syndrome)
Official title Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS
ClinicalTrials.gov ID: NCT07616037
What this study is testing
What is GLP-1/FGF21 dual agonist (HEC88473)?
GLP-1/FGF21 dual agonist (HEC88473) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for pcos (polycystic ovary syndrome).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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...
- 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 \ 45 days; ≥3 years after menarche to perimenopause: cycle length \ 35 days, or...
You likely can't join if
- 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...
- Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH...
See the full eligibility criteria
- 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.
- 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 \ 45 days; ≥3 years after menarche to perimenopause: cycle length \ 35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any...
- Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter \<10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;
- Hyperandrogenism: biochemical hyperandrogenism (total testosterone \>1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey [mFG] score \>4).
- 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.
- History of bariatric surgery within the past 12 months.
- Treatment with GLP-1 receptor agonists within the past 12 months.
- Pregnancy or lactation.
- Presence of other serious diseases of major organs such as the heart, liver, or kidney, or any malignancy.
- Any other condition that, in the investigator's opinion, may interfere with the evaluation of how well it works or safety or render the participant unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.