Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001421527
Ethics application status
Approved
Date submitted
6/11/2024
Date registered
4/12/2024
Date last updated
4/12/2024
Date data sharing statement initially provided
4/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Research Study Testing NGM120 in Pregnant Women with Severe Nausea and Vomiting (Hyperemesis Gravidarum)
Scientific 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)
Secondary ID [1] 312798 0
120-HG-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperemesis Gravidarum 334861 0
Condition category
Condition code
Reproductive Health and Childbirth 331417 331417 0 0
Antenatal care
Reproductive Health and Childbirth 331685 331685 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 331686 331686 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329334 0
Treatment: Drugs
Comparator / control treatment
A single dose of placebo (a sterile solvent, the injection solution will be provided at a concentration of 0 mg/mL NGM120) will be administered subcutaneously on either Day 1 or Day 8 of the study, according to the treatment sequence assigned.
Supportive care and SOC will be administered as described above.
Control group
Placebo

Outcomes
Primary outcome [1] 339167 0
The safety and tolerability (assessed as a composite outcome) of NGM120 in addition to SOC and supportive care.
Timepoint [1] 339167 0
Study Days 1, 5, 8, and 12, every 4 weeks thereafter until birth, at birth, 14 days postpartum, and at early termination, if applicable.
Secondary outcome [1] 438869 0
Pregnancy-Unique Quantification of Emesis 24 (PUQE-24) scores
Timepoint [1] 438869 0
Baseline and Study Day 5.
Secondary outcome [2] 438870 0
HyperEmesis Level Prediction (HELP) scores
Timepoint [2] 438870 0
Baseline and Study Day 5.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be centrally assigned to randomized study treatment using an Interactive Web Response System.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization schedule was generated prior to the study by an unblinded statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/12/2024
Actual
Date of last participant enrolment
Anticipated
18/04/2025
Actual
Date of last data collection
Anticipated
12/12/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 27120 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 27122 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 27123 0
GenesisCare - Mater Hospital - North Sydney
Recruitment hospital [4] 27124 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 27125 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 27259 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 43198 0
2031 - Randwick
Recruitment postcode(s) [2] 43200 0
4029 - Herston
Recruitment postcode(s) [3] 43201 0
2060 - North Sydney
Recruitment postcode(s) [4] 43202 0
3168 - Clayton
Recruitment postcode(s) [5] 43203 0
2170 - Liverpool
Recruitment postcode(s) [6] 43346 0
5112 - Elizabeth Vale
Recruitment outside Australia
Country [1] 26522 0
United Kingdom
State/province [1] 26522 0

Funding & Sponsors
Funding source category [1] 317231 0
Commercial sector/Industry
Name [1] 317231 0
NGM Biopharmaceuticals, Inc.
Country [1] 317231 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
NGM Biopharmaceuticals, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 319511 0
None
Name [1] 319511 0
Address [1] 319511 0
Country [1] 319511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315968 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 315968 0
Ethics committee country [1] 315968 0
Australia
Date submitted for ethics approval [1] 315968 0
28/08/2024
Approval date [1] 315968 0
29/10/2024
Ethics approval number [1] 315968 0
Ethics committee name [2] 315969 0
North East – Tyne & Wear South
Ethics committee address [2] 315969 0
Ethics committee country [2] 315969 0
United Kingdom
Date submitted for ethics approval [2] 315969 0
23/08/2024
Approval date [2] 315969 0
Ethics approval number [2] 315969 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136374 0
Prof Bill Hague
Address 136374 0
Robinson Research Institute of The University of Adelaide, 55 King William Road, North Adelaide, SA 5006
Country 136374 0
Australia
Phone 136374 0
+61 041 111 4575
Fax 136374 0
Email 136374 0
bill.hague@adelaide.edu.au
Contact person for public queries
Name 136375 0
NGM Study Director
Address 136375 0
NGM Biopharmaceuticals, Inc., 333 Oyster Point Boulevard, South San Francisco, CA 94080
Country 136375 0
United States of America
Phone 136375 0
+1 650 243 5555
Fax 136375 0
Email 136375 0
EMERALD@ngmbio.com
Contact person for scientific queries
Name 136376 0
NGM Study Director
Address 136376 0
NGM Biopharmaceuticals, Inc., 333 Oyster Point Boulevard, South San Francisco, CA 94080
Country 136376 0
United States of America
Phone 136376 0
+1 650 243 5555
Fax 136376 0
Email 136376 0
EMERALD@ngmbio.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.