Nonalcoholic SteatohepatitisPhase 2NCT03676231
Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing SGM-1019 in people with Nonalcoholic Steatohepatitis, run by Second Genome at 10 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- SGM-1019
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Jan 2019to 1 May 2019
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age 18 to 75 years, inclusive
- Elevated ALT
- F1-F3 NASH
- BMI ≥ 25
Who cannot join
- Use of prohibited medication/supplements
- Poorly controlled type 2 diabetes
- Hepatic decompensation
- Chronic liver disease
- Planned surgeries/procedures
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Second Genome Clinical Site 402
Austin, Texas, 78746
Second Genome Clinical Site 405
Chandler, Arizona, 85224
Second Genome Clinical Site 407
Clarksville, Tennessee, 37040
Second Genome Clinical Site 408
Fayetteville, North Carolina, 28304
Second Genome Clinical Site 410
Flowood, Mississippi, 39232
Second Genome Clinical Site 404
Kansas City, Missouri, 64131
Second Genome Clinical Site 409
Lakewood Rch, Florida, 34211
Second Genome Clinical Site 403
Panorama City, California, 91402
Second Genome Clinical Site 401
San Antonio, Texas, 78220
Second Genome Clinical Site 406
Tucson, Arizona, 85712
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- SGM-1019, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGM-1019Drug
Active
PlaceboDrug
Inactive
| Study group | Role | What they receive |
|---|---|---|
| High-dose SGM-1019 | Experimental | Not described Receives: Drug: SGM-1019 |
| Low-dose SGM-1019 | Experimental | Not described Receives: Drug: SGM-1019 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Summary of treatment emergent adverse events coded using MedDRA
Measured: 12 weeks
Secondary outcomes (3)
Evaluation of Pharmacokinetics - PK
Peak plasma concentration of SGM-1019 as measured by Cmax
Measured: 12 weeks
Evaluation of Pharmacodynamics - Labs
Evaluation of liver functions labs of ALT, AST, ALP, and bilirubin.
Measured: 12 weeks
Evaluation of Phamacodynamics - MRI
Evaluation of MRI parameters for assessment of liver fat, fibroinflammation, and stiffness.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start18 Jan 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Genome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew W McClure, M.D., Study director, Second Genome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676231
- Sponsor's protocol ID
- SGM-1019-102
- Status last verified
- Jul 2019
- First submitted
- 5 Sep 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT03676231
- Acronym / sponsor ID
- SGM-1019-102
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Second GenomeIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 18 Sep 2018 (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.
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose SGM-1019 | Experimental | Drug: SGM-1019 |
| Low-dose SGM-1019 | Experimental | Drug: SGM-1019 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age 18 to 75 years, inclusive
- Elevated ALT
- F1-F3 NASH
- BMI ≥ 25
Key exclusion criteria (5 listed)
- Use of prohibited medication/supplements
- Poorly controlled type 2 diabetes
- Hepatic decompensation
- Chronic liver disease
- Planned surgeries/procedures
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 |
|---|---|---|
| SGM-1019Active | Drug | High-dose SGM-1019, Low-dose SGM-1019 |
| PlaceboInactive | Drug | Placebo |
Primary outcome
Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
Time frame: 12 weeks
Summary of treatment emergent adverse events coded using MedDRA
3 secondary outcomes
Evaluation of Pharmacokinetics - PK
Time frame: 12 weeks
Evaluation of Pharmacodynamics - Labs
Time frame: 12 weeks
Evaluation of Phamacodynamics - MRI
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Nonalcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
Matthew W McClure, M.D. study director
Second Genome
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGM-1019 in people with Nonalcoholic Steatohepatitis, run by Second Genome at 10 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study terminated due to a safety event which rendered the risk-benefit profile in NASH to no longer be adequately favorable). Results are not available in the source record.
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 Safety and Tolerability - Treatment-emergent Adverse Events (time frame: 12 weeks). 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 11 Jul 2019.