ObesityPhase 1NCT04187339

Study of NGM395 in Adult Participants

A Phase 1 study testing NGM395 in people with Obesity and NAFLD, run by NGM Biopharmaceuticals, Inc at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study of NGM395 in adult participants. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity, NAFLD
What is being tested?: NGM395
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteAustralia
Study dates: 13 Feb 2020to 22 Apr 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Part 1:
Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.
Part 2:
Liver fat ≥8% as assessed by MRI-PDFF.
BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
Waist circumference > 40 inches for males or > 35 inches for females.

Who cannot join

Part 1:
Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
History of bariatric surgery.
Fasting triglycerides > 400 mg/dL at Screening.
Part 2:
Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

Trial locations and contacts

1 site in 1 country.

Australia1 site

NGM Clinical Study Site
Brisbane

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).

Study of NGM395 in adult participants.

Conditions: Obesity, NAFLD
Being tested: NGM395, Placebo
Medical subject headings: Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NGM395Biological
NGM395 Dose 1
NGM395Biological
NGM395 Dose 2
NGM395Biological
NGM395 Dose 3
NGM395Biological
NGM395 Dose 4
NGM395Biological
NGM395 Dose 5
NGM395Biological
NGM395 Dose 6
PlaceboOther
Placebo

Study groups in NCT04187339
Study group	Role	What they receive
NGM395 Dose 1	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
NGM395 Dose 2	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
NGM395 Dose 3	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
NGM395 Dose 4	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
NGM395 Dose 5	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
NGM395 Dose 6	Experimental	NGM395 Subcutaneous Injection Receives: Biological: NGM395
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.
Measured: 140 Days

Secondary outcomes (1)

Serum Concentration of NGM395
NGM395 concentration data by cohort
Measured: 140 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 202022 Apr 2021

First posted5 Dec 2019
Study start13 Feb 2020
Primary completion20 Oct 2020
Study completion22 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04187339
Sponsor's protocol ID: NGM395-OB-101
Status last verified: Jul 2021
First submitted: 3 Dec 2019
Last updated: 21 Jul 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-controlled, Double-blind, Two-part Study to Evaluate the Safety and Tolerability of NGM395 in Adult Obese Patients (Part 1) and in Adult Patients With Nonalcoholic Fatty Liver Disease (NAFLD) (Part 2).
ClinicalTrials.gov ID: NCT04187339
Acronym / sponsor ID: NGM395-OB-101
Conditions: Obesity, NAFLD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
Study start: 13 Feb 2020 (actual)
Primary completion: 20 Oct 2020 (actual)
Study completion: 22 Apr 2021 (actual)
First posted: 5 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study of NGM395 in adult participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
NGM395 Dose 1	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
NGM395 Dose 2	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
NGM395 Dose 3	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
NGM395 Dose 4	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
NGM395 Dose 5	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
NGM395 Dose 6	Experimental	Biological: NGM395NGM395 Subcutaneous Injection
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Body mass index (BMI) in the range of 27 - 45 kg/m², inclusive, at screening, with maximum body weight of 140 kg.
Liver fat ≥8% as assessed by MRI-PDFF.
BMI in the range of 27 - 45 kg/m2, inclusive, with maximum body weight of 140 kg at screening.
Waist circumference > 40 inches for males or > 35 inches for females.

Key exclusion criteria (7 listed)

Diagnosed with type 2 diabetes (T2D) and/or the use of metformin, dipeptidyl peptidase-4 (DPP4) inhibitors, sodium/glucose cotransporter 2 (SGLT2) inhibitors, sulfonylurea agents, acarbose, or insulin for T2D within 3 months prior to Screening.
Subjects with T2D managed with diet alone with HbA1c level > 6.5% or fasting glucose ≥ 126 mg/dL at Screening.
History of bariatric surgery.
Fasting triglycerides > 400 mg/dL at Screening.
Diagnosed with type 2 diabetes with a HbA1c >9.5%, on thiazolidinediones, sodium/glucose cotransporter 2 (SGLT2) inhibitors, acarbose, or insulin for T2D within 3 months prior to Screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NGM395NGM395 Dose 1	Biological	NGM395 Dose 1
NGM395NGM395 Dose 2	Biological	NGM395 Dose 2
NGM395NGM395 Dose 3	Biological	NGM395 Dose 3
NGM395NGM395 Dose 4	Biological	NGM395 Dose 4
NGM395NGM395 Dose 5	Biological	NGM395 Dose 5
NGM395NGM395 Dose 6	Biological	NGM395 Dose 6
PlaceboPlacebo	Other	Placebo

Primary outcome

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 140 Days
The number and percent of patients reporting treatment emergent adverse events (TEAEs) by cohort.

1 secondary outcome

Serum Concentration of NGM395
Time frame: 140 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

NGM Study Director study director

NGM Biopharmaceuticals, Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NGM395 in people with Obesity and NAFLD, run by NGM Biopharmaceuticals, Inc at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 140 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04187339.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.