Nonalcoholic SteatohepatitisPhase 2NCT02510599
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
A Phase 2 study testing solithromycin in people with Nonalcoholic Steatohepatitis, run by Melinta Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- solithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 28 Feb 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic evidence of NASH based on liver biopsy obtained within 180 days
- NAS> or = 5
- Able to swallow capsules intact
Who cannot join
- Symptoms of acute liver disease
- Cirrhosis on liver biopsy
- Positive HIV or Hepatitis tests
- Primary Biliary Cirrhosis
- Poorly controlled diabetes with HgA1C >8.5%
- ALT >4-fold upper limit of normal
- QTcF >450 msec
- CrCl <40 mL/min
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western University Hospitals
Cleveland, Ohio, 44106
About this study
Official title: An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
Read the detailed description
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- solithromycin
- Keywords
- NASH, Liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solithromycinDrug
Also called CEM-101
| Study group | Role | What they receive |
|---|---|---|
| Solithromycin | Experimental | Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks Receives: Drug: solithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate effects on hepatic histology in patients with NASH
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
Measured: 13 weeks
Secondary outcomes (3)
Changes in Steatosis on liver biopsy
Graded from 0 to 3
Measured: 13 weeks
Changes in hepatocellular ballooning score on liver biopsy
Graded from 0 to 2
Measured: 13 weeks
Changes in inflammation on liver biopsy
Graded from 0 to 3
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startDec 2015
- Primary completion27 Jan 2017
- Study completion28 Feb 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melinta Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Dobbins, MD, PhD, Study director, Melinta Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510599
- Sponsor's protocol ID
- CE01-205
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
- ClinicalTrials.gov ID
- NCT02510599
- Acronym / sponsor ID
- CE01-205
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- NASH, Liver disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 29 Jul 2015 (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 evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
Detailed description
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solithromycin | Experimental | Drug: solithromycinSolithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic evidence of NASH based on liver biopsy obtained within 180 days
- NAS> or = 5
- Able to swallow capsules intact
Key exclusion criteria (8 listed)
- Symptoms of acute liver disease
- Cirrhosis on liver biopsy
- Positive HIV or Hepatitis tests
- Primary Biliary Cirrhosis
- Poorly controlled diabetes with HgA1C >8.5%
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 |
|---|---|---|
| solithromycinAlso: CEM-101 | Drug | Solithromycin |
Primary outcome
To evaluate effects on hepatic histology in patients with NASH
Time frame: 13 weeks
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
3 secondary outcomes
Changes in Steatosis on liver biopsy
Time frame: 13 weeks
Changes in hepatocellular ballooning score on liver biopsy
Time frame: 13 weeks
Changes in inflammation on liver biopsy
Time frame: 13 weeks
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 Mar 2017.
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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.
Robert Dobbins, MD, PhD study director
Melinta Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solithromycin in people with Nonalcoholic Steatohepatitis, run by Melinta Therapeutics, 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 8 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 Mar 2017. 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 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 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?
To evaluate effects on hepatic histology in patients with NASH (time frame: 13 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 21 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.