A Phase 1 interventional study of GDC-0077 in Primary Ovarian Insufficiency, sponsored by Women's Hospital School Of Medicine Zhejiang University. Not yet recruiting. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Phase 1, Interventional, and Treatment
This is a single-center, single-arm, exploratory clinical trial evaluating the safety and potential effect of oral GDC-0077 on ovarian function in women with premature ovarian insufficiency (POI). GDC-0077 is an oral, highly selective PI3Kα inhibitor. Preclinical data from this research group showed that PI3Kα inhibition increased secondary and antral follicle counts in aged mice and promoted follicle development in cultured mouse ovaries. Twelve participants with POI will receive GDC-0077 9 mg orally three times weekly (Monday, Wednesday, Friday) for 3 weeks. The primary safety focus includes hyperglycemia, stomatitis/mucositis, and diarrhea. Ovarian function will be assessed by change in antral follicle count (AFC) from baseline at 3 months after treatment initiation, along with FSH, AMH, ovarian volume, and return of spontaneous menses.
Background. POI affects approximately 1-3% of women under 40 years and is characterized by oligomenorrhea or amenorrhea, elevated FSH (>25 IU/L), and low estrogen. No approved therapy restores ovarian function or natural fertility; hormone replacement therapy only alleviates hypoestrogenic symptoms. The PI3K/AKT/mTOR pathway is a core regulator of primordial follicle activation. The investigators previously observed that an oral PI3Kα inhibitor increased secondary, early antral, and large antral follicles in 12-month-old female mice without excessive depletion of the primordial follicle pool. In vitro, GDC-0077 (10 nM, 100 nM, 1 μM) enhanced follicle development in cultured postnatal day 7 mouse ovaries, supporting a direct ovarian effect.
Design and intervention. This single-center, single-arm, exploratory trial will enroll 12 women with POI. Participants will receive GDC-0077 9 mg orally three times weekly (Monday/Wednesday/Friday) for 3 weeks. The intermittent schedule is intended to limit cumulative exposure and mitigate known on-target toxicities while capturing any early follicular signal. Participants may continue hormone replacement therapy (HRT) for menstrual cycling, with agent, dose, and duration recorded; discontinuation of HRT for at least 1 month before treatment is encouraged but not mandatory.
Assessments. Baseline assessments include AFC, AMH, FSH, LH, E2, ovarian volume, fasting glucose, HbA1c, liver and renal function, coagulation, and infection markers. During the first month after treatment initiation, fasting glucose will be monitored weekly; liver and renal function will be reassessed after 1 month. At 3 months, AFC, ovarian volume, FSH, LH, E2, AMH, and occurrence of spontaneous menses will be evaluated. Participants proceeding to IVF will have oocyte retrieval, transferable embryos, good-quality embryos, and pregnancy outcomes recorded.
Safety. Known risks of PI3Kα inhibition with this compound include hyperglycemia, stomatitis/mucositis, diarrhea, and embryo-fetal toxicity. Hyperglycemia is the most frequent adverse event of special interest; fasting glucose will be monitored weekly during the first month. Pre-specified dose-modification and discontinuation rules for hyperglycemia, stomatitis, and diarrhea will be applied. Effective contraception is required during treatment and after the final dose per protocol.
181 studies on the registry are indexed under Primary Ovarian Insufficiency; 48 are open to participants now.
This study's planned enrollment of 12 is below the median of 48 across 113 interventional studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 79 studies on the registry; 49 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of POI: Serum basal FSH >25 IU/L on two occasions ≥4 weeks apart, measured on cycle days 2-4 or randomly during amenorrhea.
Willing to provide written .
Has a desire for future fertility, or does not exclude future fertility.
Exclusion Criteria:
Iatrogenic POI: prior chemotherapy, radiotherapy, or ovarian surgery (except unilateral oophorectomy with preservation of at least part of the ovarian tissue).
Abnormal liver or renal function.
Diabetes mellitus, impaired fasting glucose, or insulin resistance.
Pregnant or lactating women.
Known to GDC-0077 or any of its .
Participation in another interventional clinical trial within 3 months before enrollment.
Any condition that, in the investigator's judgment, makes the participant unsuitable for the study (e.g., psychiatric disorder, substance abuse, poor adherence).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive GDC-0077 9 mg orally three times weekly for 3 weeks.
Drug: GDC-0077
GDC-0077 9 mg film-coated tablet, oral, three times weekly (Monday/Wednesday/Friday), for 3 consecutive weeks. If a dose is missed, it should be taken as soon as remembered unless the next scheduled dose is within 12 hours, in which case the missed dose should be skipped.
Incidence of treatment-emergent adverse events (TEAEs), including hyperglycemia, stomatitis/mucositis, and diarrhea
Proportion of participants experiencing any TEAE, serious adverse event (SAE), and AEs of special interest (fasting glucose elevation, oral stomatitis/mucositis, diarrhea), graded by CTCAE v5.0. Fasting glucose will be monitored weekly during the first month after treatment initiation; other AEs will be captured throughout the 3-month follow-up.
Time frame: 3 months
Change in total antral follicle count (AFC) from baseline to 3 months after treatment initiation
Total AFC (both ovaries) assessed by transvaginal ultrasound. Baseline AFC will be recorded during screening (D-28 to D-1).
Time frame: Baseline and 3 months
Proportion of participants with ≥1 antral follicle
Measured by ultrasound
Time frame: Baseline and 3 months
Proportion of participants with ≥1 dominant follicle
Measured by ultrasound
Time frame: Baseline and 3 months
Change in ovarian volume
Measured by ultrasound
Time frame: Baseline and 3 months
Change in serum FSH, LH levels (IU/L)
Change in serum FSH, LH levels (IU/L)
Time frame: Baseline and 3 months
Proportion of participants achieving FSH <25 IU/L
Proportion of participants achieving FSH \<25 IU/L
Time frame: 3 months
Proportion of participants with ≥1 spontaneous menses (non-HRT-induced)
Proportion of participants with ≥1 spontaneous menses (non-HRT-induced)
Time frame: 3 months
IVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomes
IVF outcomes, if applicable: oocytes retrieved, transferable embryos, good-quality embryos, pregnancy outcomes
Time frame: through study completion, an average of 1 year
Change in serum E2 levels (pmol/L)
Change in serum E2 levels (pmol/L)
Time frame: Baseline and 3 months
Change in serum AMH levels (ng/ml)
Change in serum AMH levels (ng/ml)
Time frame: Baseline and 3 months
No study locations are listed for this record.
Plan to share: Undecided — This should be approved by the Ethics Committee in Women's Hospital of Zhejiang University
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inavolisib
Primary Ovarian Insufficiency →
Women's Hospital School Of Medicine Zhejiang University