Hyperemesis Gravidarum Risk Reduction With Metformin

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

October 31, 2029

Study Completion Date

October 31, 2030

Conditions
Hyperemesis Gravidarum
Interventions
DRUG

Metformin Extended Release Oral Tablet

"Participants in the Treatment Arm will receive oral extended-release metformin (metformin-XR) once daily with the evening meal starting prior to conception. The dosing will begin at 500 mg daily and increase gradually over an eight week period (+500mg every 2 weeks, as tolerated) to a maximum tolerated dose of up to 2,000 mg daily. Treatment at highest tolerated dose will continue (maintenance phase) until either two weeks after a positive pregnancy test or 12 months from treatment initiation, whichever comes first. Participants will attend three clinic visits and provide blood samples at baseline, after dose escalation, and during early pregnancy to assess GDF15 levels. Daily dosing, adherence, and any side effects are recorded via MyCap; clinical visits at baseline, post-escalation (week 8), and after pregnancy confirmation include vital signs, PUQE-24/HELP scores, and blood draws for CBC, creatinine, and GDF15 levels."

All Listed Sponsors
collaborator

The Morning Sickness & HG Clinic

UNKNOWN

lead

University of Southern California

OTHER

NCT07129473 - Hyperemesis Gravidarum Risk Reduction With Metformin | Biotech Hunter | Biotech Hunter