NCT07129473 Hyperemesis Gravidarum Risk Reduction With Metformin
| NCT ID | NCT07129473 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Southern California |
| Condition | Hyperemesis Gravidarum |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 224 participants in total. It began in 2026-07-13 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate whether daily oral metformin extended-release (metformin-XR), taken prior to and in early pregnancy, can reduce the risk and severity of Hyperemesis Gravidarum (HG), a severe nausea and vomiting condition in pregnancy, in individuals aged 18-49 who have experienced HG in a previous pregnancy and are trying to conceive. Researchers also aim to better understand which individuals may respond well - or poorly - to metformin based on biological and clinical characteristics. The main questions this study aims to answer are: 1. Is metformin-XR well-tolerated when taken by non-pregnant individuals who have had HG in a previous pregnancy and are currently trying to conceive? 2. How safe and tolerable is metformin-XR when taken at increasing doses over an 8-week titration period and continued through early pregnancy (or for up to 12 months after reaching maintenance dose if pregnancy does not occur)? 3. Among those who become pregnant during the study, does pre-pregnancy metformin-XR use reduce the risk of HG coming back and lower the severity of nausea and vomiting symptoms? 4. How does pre-pregnancy metformin-XR use affect pregnancy outcomes, postpartum health, and newborn health and development? 5. Are there specific genetic, biomarker, demographic, or clinical features that predict whether someone is likely to benefit from metformin-XR or experience side effects that lead them to stop taking it? Researchers will compare a metformin treatment group to a survey-only group (comparator, no study drug) to see if metformin-XR is associated with improved outcomes, including reduced HG recurrence and better maternal and neonatal health indicators. Participants will: Complete online questionnaires before pregnancy, during early pregnancy, and postpartum (Treatment group only) Take daily metformin-XR and attend three brief study visits (Treatment group only) Undergo blood draws at specified timepoints to assess safety and biological response
Eligibility Criteria
Inclusion Criteria: * Ages 18-49 * HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment) * Trying to conceive * Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose (up to 8 weeks total). Will use birth control or contraceptive device until maintenance dose. * Under care of a personal OB/GYN or willing to establish care with a personal OB/GYN before study start * Ownership of a personal scale (or willingness to obtain one for study use) * Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy * Treatment Arm: residing in California/Alabama * Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range) * Treatment Arm: normal to mildly decreased creatinine levels (estimated GFR \> 60 mL/min/1.73m²) * Survey/Comparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy * Able and willing to provide written informed consent prior to initiation of any study procedures. * Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * English speaking * Regular cycles Exclusion Criteria: * Allergic or adverse reaction to metformin-XR * Thalassemia * Cirrhosis and/or hepatic impairment * Decompensated heart failure * Daily/regular use of medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix) * Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication * Assisted Reproductive Technology * Excess alcohol consumption (\> 7 standard drinks per week on average) * Pregnant * Not trying to conceive * Treatment Arm: Residing outside California/Alabama * Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range) * Treatment Arm: abnormal creatinine levels (estimated GFR \< 60 mL/min/1.73m² excluded from the study, signs of kidney disease) * Treatment Arm: current metformin use * Survey/Comparator Arm: current metformin use or plans to take metformin prior to pregnancy * Any medical/surgical condition that the investigator feels would compromise the participant's participation in the study * Not able and willing to provide written informed consent prior to initiation of any study procedures. * Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * Not english speaking * Irregular cycles * Not willing to refrain from trying to conceive/use birth control or contraceptive device until maintenance dose.
Contact & Investigator
Marlena Fejzo, PhD
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT07129473 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Hyperemesis Gravidarum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07129473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07129473 currently recruiting?
Yes, NCT07129473 is actively recruiting participants. Contact the research team at Marlena.Fejzo@med.usc.edu for enrollment information.
Where is the NCT07129473 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States.
Who is sponsoring the NCT07129473 clinical trial?
NCT07129473 is sponsored by University of Southern California. The principal investigator is Marlena Fejzo, PhD at University of Southern California. The trial plans to enroll 224 participants.