NASH - Nonalcoholic SteatohepatitisPhase 1NCT04897594
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
A Phase 1 study testing TERN-201 in people with NASH - Nonalcoholic Steatohepatitis, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 11 sites in United States.
Trial summary
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- TERN-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 11 sitesUnited States
- Study dates
- 20 May 2021to 2 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, 18 to 75 years of age
- Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
- Presumed NASH based on clinical characteristics or prior liver biopsy
- ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
- MRI-cT1 value> 800 ms
- Written informed consent
Who cannot join
- History or clinical evidence of chronic liver diseases other than NAFLD
- History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
- History of liver transplant, or current placement on a liver transplant list
- Weight loss of > 5% total body weight within 3 months prior to Screening
- Note: Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Terns Clinical Study Site 1010
Bastrop, Louisiana, 71220
Terns Clinical Study Site 1004
Coronado, California, 92117
Terns Clinical Study Site 1039
Los Angeles, California, 90048
Terns Clinical Study Site 1001
Panorama City, California, 91402
Terns Clinical Study Site 1040
Rialto, California, 92377
Terns Clinical Study Site 1006
San Antonio, Texas, 78215
Terns Clinical Study Site 1003
San Antonio, Texas, 78229
Terns Clinical Study Site 1019
San Antonio, Texas, 78229
Terns Clinical Study Site 1013
San Diego, California, 92093
Terns Clinical Study Site 1018
Tucson, Arizona, 85712
Terns Clinical Study Site 1024
Tucson, Arizona, 85712
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- TERN-201, Placebo
- Keywords
- Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO), Nonalcoholic steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
- 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.
TERN-201Drug
Investigational drug
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| TERN-201 10mg | Experimental | Orally administered Receives: Drug: TERN-201 |
| TERN-201 20mg | Experimental | Orally Administered Receives: Drug: TERN-201 |
| Placebo | Placebo comparator | Orally administered Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Measured: Day 1 through Week 16
Treatment-Emergent Laboratory Abnormalities
Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category.
CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Measured: Day 1 through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start20 May 2021
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NASH - 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- clinicaltrials@ternspharma.com, Study director, Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897594
- Sponsor's protocol ID
- TERN201-1007
- Status last verified
- Dec 2023
- First submitted
- 18 May 2021
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT04897594
- Acronym / sponsor ID
- TERN201-1007
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO), Nonalcoholic steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 7 Jun 2024
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 Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TERN-201 10mg | Experimental | Drug: TERN-201Orally administered |
| TERN-201 20mg | Experimental | Drug: TERN-201Orally Administered |
| Placebo | Placebo comparator | Other: PlaceboOrally administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 to 75 years of age
- Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
- Presumed NASH based on clinical characteristics or prior liver biopsy
- ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
- MRI-cT1 value> 800 ms
Key exclusion criteria (5 listed)
- History or clinical evidence of chronic liver diseases other than NAFLD
- History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
- History of liver transplant, or current placement on a liver transplant list
- Weight loss of > 5% total body weight within 3 months prior to Screening
- Note: Other protocol-defined inclusion/exclusion criteria could apply.
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 |
|---|---|---|
| TERN-201Investigational drug | Drug | TERN-201 10mg, TERN-201 20mg |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Patient Incidence of Adverse Events for TERN-201 Versus Placebo
Time frame: Day 1 through Week 16
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Treatment-Emergent Laboratory Abnormalities
Time frame: Day 1 through Week 16
Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category. CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
clinicaltrials@ternspharma.com study director
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TERN-201 in people with NASH - Nonalcoholic Steatohepatitis, run by Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 11 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 6 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Incidence of Adverse Events for TERN-201 Versus Placebo (time frame: Day 1 through Week 16). The study lists 2 primary outcomes in all. 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 7 Jun 2024.