ObesePhase 1NCT03298464
Study of NGM313 in Obese Participants
A Phase 1 study testing NGM313 and Pioglitazone in people with Obese, run by NGM Biopharmaceuticals, Inc at 1 site in United States.
Trial summary
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obese
- What is being tested?
- NGM313 and Pioglitazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2017to 17 Jul 2018
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) of 30-43 kg/m2
- Waist circumference > 40 inches in males or > 30 inches in females
- Normal ECG readings
Who cannot join
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of any known Congestive heart failure (CHF)
- History of macrovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
- Conditions
- Obese
- Being tested
- NGM313, Pioglitazone
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGM313Biological
Subcutaneous injection
PioglitazoneDrug
White to off-white round tablet
| Study group | Role | What they receive |
|---|---|---|
| NGM313 | Experimental | Not described Receives: Biological: NGM313 |
| Pioglitazone | Active comparator | Not described Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start11 Sep 2017
- Primary completion19 Jun 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298464
- Sponsor's protocol ID
- 17-0202
- Status last verified
- Mar 2019
- First submitted
- 22 Sep 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat
- ClinicalTrials.gov ID
- NCT03298464
- Acronym / sponsor ID
- 17-0202
- Conditions
- Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NGM Biopharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 2 Oct 2017 (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.
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGM313 | Experimental | Biological: NGM313 |
| Pioglitazone | Active comparator | Drug: Pioglitazone |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) of 30-43 kg/m2
- Waist circumference > 40 inches in males or > 30 inches in females
- Normal ECG readings
Key exclusion criteria (3 listed)
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of any known Congestive heart failure (CHF)
- History of macrovascular disease
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 |
|---|---|---|
| NGM313Subcutaneous injection | Biological | NGM313 |
| PioglitazoneWhite to off-white round tablet | Drug | Pioglitazone |
Primary outcome
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration
Time frame: 28 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 13 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NGM313 and Pioglitazone in people with Obese, run by NGM Biopharmaceuticals, Inc at 1 site in United States.
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 3 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 13 Mar 2019. 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 United States. 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?
Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration (time frame: 28 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 13 Mar 2019.