ClinicalTrials.gg
CompletedNCT03392116Updated Aug 20, 2019

Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects

A Phase 1 interventional study of NGM120 and Placebo in Cachexia, sponsored by NGM Biopharmaceuticals, Inc. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by NGM Biopharmaceuticals, Inc · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Cachexia with a site in Australia — 3 open to participants now, 3 under way, 1 of them phase 3. Cachexia · Australia.

Enrollment
7th of 11
92 · median 124
Started
2018
the only one that year
Phase 1
2 of 11
none open now
Registered
5th of 11
by date
Lead sponsor
1 of 11
NGM Biopharmaceuticals, Inc

Among the 11 studies in Cachexia with a site in Australia, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 2 in phase 1, and was the 5th registered.

Cachexia

331 studies on the registry are indexed under Cachexia; 74 are open to participants now.

Browse Cachexia studies →

Open to participants now

3 of the 11 studies in Cachexia with a site in Australia are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →

Who these studies take

Of the 55 Cachexia studies recruiting now, 32 (58%) set no upper age limit and 14 (25%) stop at 75 or younger; 7 take children under 18; 16 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

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02

Study summary

The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects

03

Conditions studied

  • Cachexia

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Normal findings

Exclusion criteria

Exclusion Criteria:

  • Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Investigator)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    Part A: NGM120

    Single Dose

    Biological: NGM120

  • Placebo comparator
    Part A: Placebo

    Single Dose

    Other: Placebo

  • Experimental
    Part B: NGM120

    Multiple Dose

    Biological: NGM120

  • Placebo comparator
    Part B: Placebo

    Multiple Dose

    Other: Placebo

Interventions

  • BiologicalNGM120

    Subcutaneous Injection

  • OtherPlacebo

    Subcutaneous Injection

06

What researchers measure

Primary outcomes

  1. Part A Arm-Single Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    Time frame: 28 days

  2. Part B Arm-Multiple Dose: Treatment Emergent Adverse events

    Percentage of total subjects with Treatment Emergent Adverse event

    Time frame: 84 days

07

Study locations

1 site
  • Nucleus Network Limited
    Melbourne, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jan 2019, 11 months.

Of 21 phase 1 interventional studies under Cachexia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 11 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Jan 5, 2018
StartActual
Jan 29, 2018
Primary completionActual
Jan 14, 2019
CompletionActual
Mar 11, 2019
Last update
Aug 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03392116
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Jan 29, 2018
Primary completion
Jan 14, 2019
Completion
Mar 11, 2019
Last update
Aug 20, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Anti-GFRAL Monoclonal Antibody NGM120

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