None listed
Conditions
Brief summary
This study is a multicenter, randomized, single blind (participant and Investigator blinded), placebo-controlled Phase 2 study, with a 2-group, 2-period crossover design. The aim of the study is to evaluate the safety and tolerability of NGM120 in pregnant women with HG, as well as to obtain evidence of relief of HG symptoms, as measured by PRO, including PUQE-24, HELP, nausea numerical rating scale (NRS), daily activities NRS, and well-being NRS. The study aims to show that NGM120 is safe to take and able to relieve HG symptoms (severe nausea and vomiting) in pregnant women by completing patient questionnaires.
Interventions
The study drug is NGM120, a humanized monoclonal antibody. A single dose (75 mg) will be administered subcutaneously (SC) by the study center staff on either Day 1 (the first day of Study Period 1, which runs from Day 1 through Day 7) or Day 8 (the first day of Study Period 2, which runs from Day 8 through Day 12) of the study, according to the treatment sequence assigned.
There is no wash out between administration of the first assigned treatment on Day 1 and administration of the second assi
The study drug is NGM120, a humanized monoclonal antibody. A single dose (75 mg) will be administered subcutaneously (SC) by the study center staff on either Day 1 (the first day of Study Period 1, which runs from Day 1 through Day 7) or Day 8 (the first day of Study Period 2, which runs from Day 8 through Day 12) of the study, according to the treatment sequence assigned. There is no wash out between administration of the first assigned treatment on Day 1 and administration of the second assigned treatment on Day 8. As supportive care, participants will receive intravenous (IV) fluids with multivitamins administered on Study Days -3, 1, 5, and 8, regardless of the treatment sequence to which they are assigned. Participants will receive IV multivitamins according to the standard of care (SOC) at each study center. Additionally, participants will receive 4 mg ondansetron 3 times daily as SOC, administered orally or sublingually.
The study drug is NGM120, a humanized monoclonal antibody. A single dose (75 mg) will be administered subcutaneously (SC) by the study center staff on either Day 1 (the first day of Study Period 1, which runs from Day 1 through Day 7) or Day 8 (the first day of Study Period 2, which runs from Day 8 through Day 12) of the study, according to the treatment sequence assigned.
There is no wash out between administration of the first assigned treatment on Day 1 and administration of the second assign
The study drug is NGM120, a humanized monoclonal antibody. A single dose (75 mg) will be administered subcutaneously (SC) by the study center staff on either Day 1 (the first day of Study Period 1, which runs from Day 1 through Day 7) or Day 8 (the first day of Study Period 2, which runs from Day 8 through Day 12) of the study, according to the treatment sequence assigned. There is no wash out between administration of the first assigned treatment on Day 1 and administration of the second assigned treatment on Day 8. Additionally, participants will continue anti-emetics, supportive care, or other treatments for HG as per local guidelines with no changes in HG medications and their doses from Day -3 to Day 12.
Sponsors
NGM Biopharmaceuticals, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnant females with singleton pregnancy and gestational age of the fetus is 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 (HG) and will receive ondansetron and IV fluids per protocol.
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.
Outcome results
None listed