Hyperemesis gravidarum Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 30/07/2025:
The study drug is NGM120, a humanised monoclonal antibody. Participants will be randomised to receive a single dose of NGM120 or placebo (a sterile solvent with
Sponsors
NGM Biopharmaceuticals, Inc.
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 30/07/2025: 1. Pregnant females with singleton pregnancy (including vanishing twin syndrome) and gestational age of the foetus is between 9 to less than 17 weeks. 2. Severe nausea and vomiting with PUQE-24 greater than or equal to 12 3. Agree to no changes in any current anti-emetics or other treatments for hyperemesis gravidarum and will receive treatments and supportive care per normal practice from Day -3 to Day 12. Previous inclusion criteria as of 06/02/2025: 1. Pregnant females with singleton pregnancy and gestational age of the fetus is between 10 to 15 weeks. 2. Severe nausea and vomiting with PUQE-24 greater than or equal to 13 3. Agree to discontinue any current anti-emetics or other treatments for hyperemesis gravidarum and will receive ondansetron and IV fluids per protocol. Previous inclusion criteria: 1. Pregnant females with singleton pregnancy and gestational age of the fetus is between 10 to 15 weeks. 2. Severe nausea and vomiting with PUQE-24 greater than or equal to 13 3. Agree to discontinue any current anti-emetics or other treatments for hyperemesis gravidarum.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/07/2025: 1. History of cyclic vomiting or gastroparesis which could contribute to the aetiology of nausea and vomiting 2. Prior health conditions (i.e. bowel obstruction, pancreatitis, surgical adhesions in bowel) which could contribute to the aetiology of nausea and vomiting 3. Have active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection. 4. Pre-existing diagnosis of chronic kidney disease, uncontrolled diabetes (type 1 or 2), significant cardiac disease (including long QT syndrome) or epilepsy 5. Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase greater than or equal to 3.0 times the upper limit of normal) 6. Known foetal chromosomal abnormalities Previous exclusion criteria: 1. History of cyclic vomiting or gastroparesis which could contribute to the etiology of nausea and vomiting 2. Prior bariatric surgery, bowel obstruction, pancreatitis, or other prior health conditions which could contribute to the etiology of nausea and vomiting 3. Positive for hepatitis B surface antigen, hepatitis C viral load RNA, or anti-human immunodeficiency virus 4. Pre-existing diagnosis of chronic kidney disease, diabetes (type 1 or 2), significant cardiac disease (including long QT syndrome) or epilepsy 5. Elevated liver enzymes (alanine aminotransferase or aspartate aminotransferase greater than or equal to 3.0 times the upper limit of normal) 6. Known fetal chromosomal abnormalities 7. Pregnancy conceived through in vitro fertilization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of NGM120 in addition to SOC, assessed by the incidence of treatment-emergent adverse events (TEAEs) characterised by type, frequency, severity, timing, seriousness, and relationship to the study drug over time. Specific timepoints for evaluation include Study Day 1, when the initial dose of the investigational product is administered, and continuously through Study Day 12, to monitor any adverse events following treatment. At each scheduled visit or contact, adverse events will be recorded to track their type, frequency, severity, timing, and seriousness, along with their relationship to the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nausea, vomiting, and retching assessed using the Pregnancy-Unique Quantification of Emesis 24 score (PUQE-24) at Baseline and Study Day 5 2. Nausea, vomiting, retching, and overall wellbeing assessed using the HyperEmesis Level Prediction (HELP) score at Baseline and Study Day 5 | — |
Countries
Australia, England, Philippines, United Kingdom
Outcome results
None listed