NAFLDPhase 2NormaliZEDNCT05305599
Different Doses of ZED1227 vs. Placebo in NAFLD
A Phase 2 study testing ZED1227 in people with NAFLD and Liver Fibrosis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NAFLD, Liver Fibrosis
- What is being tested?
- ZED1227
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteGermany
- Study dates
- 19 Apr 2022to 5 Jul 2023
- 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
- Has provided signed informed consent
- Is a male or female ≥ 18 and < 75 years of age
- Has diagnosed NAFLD
- Has diagnosed significant fibrosis (stages 2 or 3)
Who cannot join
- Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males)
- Has a history or presence of any other significant concomitant liver diseases
- Has diagnosed type 1 diabetes mellitus (T1DM)
- Has presence of cirrhosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis
This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.
- Conditions
- NAFLD, Liver Fibrosis
- Being tested
- ZED1227, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZED1227Drug
ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2).
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ZED1227 (low dose) 10 mg | Experimental | Not described Receives: Drug: ZED1227 |
| ZED1227 (middle dose) 25 mg | Experimental | Not described Receives: Drug: ZED1227 |
| ZED1227 (high dose) 50 mg | Experimental | Not described Receives: Drug: ZED1227 |
| 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.
Relative change of PRO-C3 levels
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
Measured: 12 weeks
Secondary outcomes (1)
Incidence of adverse events
Incidence of treatment-emergent adverse events.
Measured: from baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start19 Apr 2022
- Primary completion7 Jun 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305599
- Sponsor's protocol ID
- CEC-11/NAS
- Acronym
- NormaliZED
- Status last verified
- May 2024
- First submitted
- 4 Mar 2022
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis
- ClinicalTrials.gov ID
- NCT05305599
- Acronym / sponsor ID
- NormaliZED / CEC-11/NAS
- Conditions
- NAFLD, Liver Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 31 Mar 2022 (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 double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ZED1227 (low dose) 10 mg | Experimental | Drug: ZED1227 |
| ZED1227 (middle dose) 25 mg | Experimental | Drug: ZED1227 |
| ZED1227 (high dose) 50 mg | Experimental | Drug: ZED1227 |
| 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 (4 listed)
- Has provided signed informed consent
- Is a male or female ≥ 18 and < 75 years of age
- Has diagnosed NAFLD
- Has diagnosed significant fibrosis (stages 2 or 3)
Key exclusion criteria (4 listed)
- Has a history of significant alcohol consumption (an average of > 20 g/d in females and > 30 g/d in males)
- Has a history or presence of any other significant concomitant liver diseases
- Has diagnosed type 1 diabetes mellitus (T1DM)
- Has presence of cirrhosis
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 |
|---|---|---|
| ZED1227ZED1227 is a peptidomimetic designed to inhibit the activity of human tissue transglutaminase 2 (TG2). | Drug | ZED1227 (high dose) 50 mg, ZED1227 (low dose) 10 mg, ZED1227 (middle dose) 25 mg |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Relative change of PRO-C3 levels
Time frame: 12 weeks
Relative change (%) of serum levels of PRO-C3 between baseline and the EOT.
1 secondary outcome
Incidence of adverse events
Time frame: from baseline to 16 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 14 May 2024.
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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 2 study testing ZED1227 in people with NAFLD and Liver Fibrosis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
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 4 inclusion and 4 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 14 May 2024. 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 Germany. 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 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?
Relative change of PRO-C3 levels (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 14 May 2024.