Diabetes MellitusPhase 1NCT01776528
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
A Phase 1 study testing NGM282 in people with Diabetes Mellitus, run by NGM Biopharmaceuticals, Inc at 1 site in Australia.
Trial summary
The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- NGM282
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2013to Jul 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, between 18 and 65 years of age, inclusive
- BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
- In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1
Who cannot join
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
- Conditions
- Diabetes Mellitus
- Being tested
- NGM282, Placebo
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM282Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 SAD | Experimental | NGM282 Dose 1 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 2 SAD | Experimental | NGM282 Dose 2 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 3 SAD | Experimental | NGM282 Dose 3 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 4 SAD | Experimental | NGM282 Dose 4 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 5 SAD | Experimental | NGM282 Dose 5 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 6 SAD | Experimental | NGM282 Dose 6 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 7 MAD | Experimental | NGM282 Dose 1 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 8 MAD | Experimental | NGM282 Dose 2 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 9 MAD | Experimental | NGM282 Dose 3 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 10 MAD | Experimental | NGM282 Dose 4 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 11 MAD | Experimental | NGM282 Dose 5 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
| Cohort 12 MAD | Experimental | NGM282 Dose 6 vs Placebo Receives: Biological: NGM282; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Measured: 7 days and 14 days
Secondary outcomes (2)
Pharmacokinetics
To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Measured: 7 days and 14 days
Pharmacodynamics
To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
Measured: 7 days and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alex M DePaoli, MD, Study director, NGM Biopharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776528
- Sponsor's protocol ID
- 12-0101
- Status last verified
- Dec 2013
- First submitted
- 18 Jan 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT01776528
- Acronym / sponsor ID
- 12-0101
- Conditions
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jan 2013 (estimated)
- 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.
The purpose of this study is to determine the safety and tolerability of NGM282, both single dose and multiple doses, in normal healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 1 vs Placebo |
| Cohort 2 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 2 vs Placebo |
| Cohort 3 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 3 vs Placebo |
| Cohort 4 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 4 vs Placebo |
| Cohort 5 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 5 vs Placebo |
| Cohort 6 SAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 6 vs Placebo |
| Cohort 7 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 1 vs Placebo |
| Cohort 8 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 2 vs Placebo |
| Cohort 9 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 3 vs Placebo |
| Cohort 10 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 4 vs Placebo |
| Cohort 11 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 5 vs Placebo |
| Cohort 12 MAD | Experimental | Biological: NGM282, Biological: PlaceboNGM282 Dose 6 vs Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, between 18 and 65 years of age, inclusive
- BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for the MAD Module at Screening;
- In good health, determined by no clinically significant findings from medical history, physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1
Key exclusion criteria (2 listed)
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disorder (as determined by the PI)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
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 |
|---|---|---|
| NGM282 | Biological | Cohort 1 SAD, Cohort 10 MAD, Cohort 11 MAD, Cohort 12 MAD, Cohort 2 SAD, Cohort 3 SAD, Cohort 4 SAD, Cohort 5 SAD, Cohort 6 SAD, Cohort 7 MAD, Cohort 8 MAD, Cohort 9 MAD |
| Placebo | Biological | Cohort 1 SAD, Cohort 10 MAD, Cohort 11 MAD, Cohort 12 MAD, Cohort 2 SAD, Cohort 3 SAD, Cohort 4 SAD, Cohort 5 SAD, Cohort 6 SAD, Cohort 7 MAD, Cohort 8 MAD, Cohort 9 MAD |
Primary outcome
Safety and tolerability
Time frame: 7 days and 14 days
To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
2 secondary outcomes
Pharmacokinetics
Time frame: 7 days and 14 days
Pharmacodynamics
Time frame: 7 days and 14 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 31 Dec 2013.
- Related InfoLink provided by the sponsor.
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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.
Alex M DePaoli, MD 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 NGM282 in people with Diabetes Mellitus, 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 3 inclusion and 2 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 31 Dec 2013. 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. 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?
Safety and tolerability (time frame: 7 days and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2013.