Primary Ovarian InsufficiencyPhase 1NCT07904208
Oral GDC-0077 in Premature Ovarian Insufficiency
A Phase 1 study testing GDC-0077 in people with Primary Ovarian Insufficiency, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- What is being tested?
- GDC-0077
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female, aged 20-40 years inclusive.
- 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 informed consent.
- Has a desire for future fertility, or does not exclude future fertility.
Who cannot join
- Known chromosomal abnormality in the participant.
- 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 hypersensitivity to GDC-0077 or any of its excipients.
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Single-Arm, Exploratory Clinical Trial of Oral Inavolisib in Patients With Premature Ovarian Insufficiency
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.
Read the detailed description
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.
- Conditions
- Primary Ovarian Insufficiency
- Being tested
- GDC-0077
- Keywords
- ovarian reserve, antral follicle count, PI3K alpha inhibitor, primary ovarian insufficiency
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-0077Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral GDC-0077 | Experimental | Participants receive GDC-0077 9 mg orally three times weekly for 3 weeks. Receives: Drug: GDC-0077 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline and 3 months
Secondary outcomes (9)
Proportion of participants with ≥1 antral follicle
Measured by ultrasound
Measured: Baseline and 3 months
Proportion of participants with ≥1 dominant follicle
Measured by ultrasound
Measured: Baseline and 3 months
Change in ovarian volume
Measured by ultrasound
Measured: Baseline and 3 months
Change in serum FSH, LH levels (IU/L)
Change in serum FSH, LH levels (IU/L)
Measured: Baseline and 3 months
Proportion of participants achieving FSH <25 IU/L
Proportion of participants achieving FSH <25 IU/L
Measured: 3 months
Proportion of participants with ≥1 spontaneous menses (non-HRT-induced)
Proportion of participants with ≥1 spontaneous menses (non-HRT-induced)
Measured: 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
Measured: through study completion, an average of 1 year
Change in serum E2 levels (pmol/L)
Change in serum E2 levels (pmol/L)
Measured: Baseline and 3 months
Change in serum AMH levels (ng/ml)
Change in serum AMH levels (ng/ml)
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Zhang, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904208
- Sponsor's protocol ID
- POSIT Trial
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This should be approved by the Ethics Committee in Women's Hospital of Zhejiang University
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Exploratory Clinical Trial of Oral Inavolisib in Patients With Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT07904208
- Acronym / sponsor ID
- POSIT Trial
- Conditions
- Primary Ovarian Insufficiency
- Keywords
- ovarian reserve, antral follicle count, PI3K alpha inhibitor, primary ovarian insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral GDC-0077 | Experimental | Drug: GDC-0077Participants receive GDC-0077 9 mg orally three times weekly for 3 weeks. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female, aged 20-40 years inclusive.
- 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 informed consent.
- Has a desire for future fertility, or does not exclude future fertility.
Key exclusion criteria (8 listed)
- Known chromosomal abnormality in the participant.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-0077GDC-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. | Drug | Oral GDC-0077 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs), including hyperglycemia, stomatitis/mucositis, and diarrhea
Time frame: 3 months
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.
Change in total antral follicle count (AFC) from baseline to 3 months after treatment initiation
Time frame: Baseline and 3 months
Total AFC (both ovaries) assessed by transvaginal ultrasound. Baseline AFC will be recorded during screening (D-28 to D-1).
9 secondary outcomes
Proportion of participants with ≥1 antral follicle
Time frame: Baseline and 3 months
Proportion of participants with ≥1 dominant follicle
Time frame: Baseline and 3 months
Change in ovarian volume
Time frame: Baseline and 3 months
Change in serum FSH, LH levels (IU/L)
Time frame: Baseline and 3 months
Proportion of participants achieving FSH <25 IU/L
Time frame: 3 months
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
Time frame: through study completion, an average of 1 year
Change in serum E2 levels (pmol/L)
Time frame: Baseline and 3 months
Change in serum AMH levels (ng/ml)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided. This should be approved by the Ethics Committee in Women's Hospital of Zhejiang University
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-0077 in people with Primary Ovarian Insufficiency, run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Lun Dr Hu, MD (86+15901575271, 11918387@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs), including hyperglycemia, stomatitis/mucositis, and diarrhea (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.