NGM 120-HG-201

• Research type

  Research Study

• Full title

  A Phase 2 Randomized, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of NGM120 in Pregnant Women with Severe Nausea and Vomiting (Hyperemesis Gravidarum).

• IRAS ID

  1010482

• Contact name

  Lingxing Zheng

• Contact email

  lzheng@ngmbio.com

• Sponsor organisation

  NGM Biopharmaceuticals, Inc.

• ISRCTN Number

  ISRCTN76681798

• Research summary

  This clinical trial aims to help pregnant women suffering from severe nausea and vomiting, known as Hyperemesis Gravidarum (HG). HG can lead to significant weight loss, multiple hospital admissions and other pregnancy complications including fetal growth problems and earlier delivery (preterm delivery). In severe cases, women may even consider terminating their pregnancies due to the severity of the illness.
  Currently, there are limited treatments available for HG. This trial will test NGM120, a monoclonal antibody, to see if it is safe and effective for treating HG. The study will involve 30 pregnant women between 10 and 15 weeks of pregnancy who are experiencing severe nausea and vomiting. The participants will be divided into two groups, both receiving the standard care of ondansetron, fluids, and vitamins. One group will also receive NGM120, while the other will receive a placebo. After a week, the groups will switch treatments, allowing all participants to try both NGM120 and the placebo. The study treatment lasts for 12 days.
  Researchers will closely monitor the participants to ensure safety and assess the effectiveness of NGM120 in reducing nausea and improving daily functioning. To join the study, women must be between 18 and 40 years old, have a healthy single pregnancy, and agree to stop using other HG treatments during the trial. Certain health conditions and behaviours, such as high blood pressure or smoking, may exclude some women from participating. The study will also track any side effects, analyse how the drug moves through the body, and examine its impact on the baby's birth weight and delivery. The goal is to better understand how to treat severe nausea during pregnancy and develop more effective treatments for the future.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  24/NE/0177

• Date of REC Opinion

  24 Oct 2024

• REC opinion

  Further Information Favourable Opinion