Monash Women’s Maternity is pleased to share news of a new commercially sponsored trial, Emerald, that is exploring a new treatment for hyperemesis gravidarum (HG) during pregnancy.
The trial is looking to recruit as many women with HG as possible, aged between 18 and 45 years and between 9 to 16+6 weeks of gestation with a Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score of 12 or more.
Background
Led by NGM Biopharmaceuticals, Emerald (120-HG-201) is a Phase 2, randomised, proof of concept clinical trial that aims to evaluate the safety, tolerability and efficacy of their new monoclonal antibody (NGM120) in pregnant women with hyperemesis.
The trial is a crossover design where participants will receive a single dose (75mg SC) of either the study drug or placebo on day 1, and then the alternate on day 8, with safety assessments (including standard care of IV fluids and multivitamins) performed regularly over a 2-week period, and safety follow-up calls carried out monthly until delivery and in the postpartum period.
More information
- Participant poster: you can share this poster with potential patients.
- Supplementary info summary: for more details on the trail
- How does the study drug work: video explaining the drug being tested in this trial
- The participant journey: video explaining the trial journey
For any queries or patient referrals please feel free to reach out to Principal Investigator, Prof Kirsten Palmer and Study Coordinator, Anthony Nisi at maternityclinicaltrials@monashhealth.org or by calling 0493 659 630.