Nonalcoholic Steatohepatitis (NASH)Phase 1/2NCT04004325

A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis

A Phase 1/2 study testing FT-4101 and Deuterated Water in people with Nonalcoholic Steatohepatitis (NASH) and Overweight or Obesity, run by Forma Therapeutics, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
What is being tested?: FT-4101 and Deuterated Water
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: 17 May 2019to 20 Jan 2020
Phase: Phase 1/2
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

Meets all of the following criteria:
CAP ≥ 300 dB/m by FibroScan® OR Liver biopsy within 24 months, consistent with NASH with stage 2-3 fibrosis
Screening MRI-PDFF with ≥ 10% steatosis.
Body mass index (BMI) > 25.0 to < 45.0 kg/m2
Stable body weight
Subjects with T2DM may also be included, if:

Show all 11Show fewer

Subject with T2DM is on stable doses of metformin monotherapy (subjects on combination therapy of metformin and sulfonylurea (SU) need to undergo washout period prior to dosing) with no changes in medication within the previous 6 months
HbA1c < 9% (one retest is permitted with the result of the last test being conclusive)
Fasting plasma glucose (FPG) < 240 mg/dL (<13.3 mmol/L)
Waist circumference ≤ 57 inches
Female subjects must be non-pregnant and non-lactating

Who cannot join

Type 1 diabetes and type 2 diabetic subjects on insulin therapy
Diabetic complications, such as acute proliferative retinopathy
Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis
History of, or active, chronic liver disease due to alcohol, auto-immune, primary biliary cholangitis, HIV, HBV or active HCV-infection, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, etc., and not due to NASH disease
History of clinically significant or decompensated chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or MELD score ≥ 10.
History of significant cirrhosis of the liver

Show all 26Show fewer

Alcohol consumption greater than 14 drinks per week for men or greater than 7 drinks per week for women and/or positive alcohol breath test
Introduction of an anti-obesity drug in the past 6 months prior to screening
History of gastrointestinal malabsorptive bariatric surgery, any other gastrointestinal surgery that may induce malabsorption, history of bowel resection > 20 cm, any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss, as well as clinically significant gastrointestinal disorders within less than 5 years
Ingestion of drugs known to produce hepatic steatosis including corticosteroids, high- dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months
History of, or current cardiac dysrhythmias and/or a history of cardiovascular disease events, including congestive heart failure, unstable coronary artery disease, myocardial infarction
Significant systemic or major illnesses other than liver disease, including cerebrovascular disease, pulmonary disease, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator, would preclude treatment with FT-4101 and/or adequate follow up
History of chronic skin conditions such as psoriasis, eczema or any recurring rash/dermatitis requiring oral or topical corticosteroids or other topical applications within 12 months
Hair loss or unexplained alopecia within 12 months
History of chronic eye conditions, Sjögren syndrome or any history of dry eyes or allergic conjunctivitis requiring artificial tears or medicated eye drops or previous refractive surgery within 12 months (Subjects with dry eyes due to wearing contact lenses are eligible)
History of major depression, anxiety, suicidal behavior or attempts, or other unstable psychiatric disorders (within 2 years of screening), requiring medical treatment
Uncontrolled hypertension
Any device or other contraindication with the MRI examination
Ingestion of deuterated water within the previous 6 months
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) antibody
Participation in any other clinical interventional study receiving active treatment within the previous 30 days or 5 half-lives, whichever is longer
Unable to abstain from smoking during confinement periods
History of illicit drug abuse
Clinically under the effect of marijuana at screening
Unwillingness to abstain from grapefruit (grapefruit containing food and beverages), star fruit (carambola), pomegranate, Seville orange and other food components that may interact with CYP3A4 from check-in throughout the entire course of the study
Donation or loss of > 500 mL of blood or blood product within 56 days of dosing

Trial locations and contacts

2 sites in 1 country.

United States2 sites

ProSciento, Inc.
Chula Vista, California, 91911
Catalina Research Institute
Montclair, California, 91763

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH

This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH.

The study may be conducted in up to 2 dosing cohorts.

Conditions: Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
Being tested: FT-4101, FT-4101 placebo, Deuterated Water
Medical subject headings: Non-alcoholic Fatty Liver Disease, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FT-4101Drug
FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level.
FT-4101 placeboDrug
FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.
Deuterated WaterOther
Deuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%).

Study groups in NCT04004325
Study group	Role	What they receive
Cohort A	Experimental	Not described Receives: Drug: FT-4101; Drug: FT-4101 placebo; Other: Deuterated Water
Cohort B	Experimental	Not described Receives: Drug: FT-4101; Drug: FT-4101 placebo; Other: Deuterated Water

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as an adverse events (AEs) with an onset that occurred after receiving the first dose of the study drug (AE start date greater than or equal to [>=] first dose date) and within 30 days after receiving the last dose of the study drug (AE start date - last dose date less than or equal to [<=] 30). Number of participants with TEAEs are reported.
Measured: From start of study drug administration up to 20 weeks
Number of Participants With Clinically Significant Changes in Laboratory Values
Number of participants with clinically significant changes in laboratory values (hematology, serum chemistry, and urinalysis) are reported.
Measured: Up to 20 weeks
Number of Participants With Clinically Significant Changes in Physical Examination
Number of participants with clinically significant changes in physical examination are reported.
Measured: Up to 20 weeks
Change From Baseline in Vital Signs: Blood Pressure (BP)
Change from baseline in blood pressure (systolic and diastolic) are reported.
Measured: Baseline, Day 92
Change From Baseline in Vital Signs: Heart Rate (HR)
Change from baseline in heart rate is reported.
Measured: Baseline, Day 92
Change From Baseline in Vital Signs: Respiratory Rate
Change from baseline in respiratory rate is reported.
Measured: Baseline, Day 92
Change From Baseline in Vital Signs: Temperature
Change from baseline in temperature is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: ECG Mean Heart Rate
Change from baseline in ECG mean heart rate is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead ECG Parameters: QT Interval
Change from baseline in QT interval is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead ECG Parameters: PR Interval
Change from baseline in PR interval is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead ECG Parameters: QRS Interval
Change from baseline in QRS interval is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead ECG Parameters: RR Interval
Change from baseline in RR interval is reported.
Measured: Baseline, Day 92
Change From Baseline in 12-lead ECG Parameters: QTc (Corrected) Using the Fridericia Correction (QTcF) Interval
Change from baseline in QTcF interval is reported.
Measured: Baseline, Day 92
Percent Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF)
Percent change from baseline in liver fat on MRI-PDFF is reported.
Measured: At week 12
Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF)
Change from baseline in percentage of liver fat on MRI-PDFF is reported.
Measured: At week 12

Secondary outcomes (11)

Change From Baseline in Liver Fat on MRI-PDFF
Change from baseline in percentage of liver fat on MRI-PDFF is reported.
Measured: At week 6
Percent Change From Baseline in Liver Fat on MRI-PDFF
Percent change from baseline in liver fat on MRI-PDFF is reported.
Measured: At week 6
Percentage of Participants Experiencing a Relative Reduction of 30% or Greater of Liver Fat as Assessed by MRI-PDFF
Percentage of participants experiencing a relative reduction of 30% or greater of liver fat as assessed by MRI-PDFF at week 12 are reported.
Measured: At week 12
Change From Baseline in Alanine Aminotransferase (ALT)
Change from baseline in ALT is reported.
Measured: Baseline, Day 92
Change From Baseline in Aspartate Aminotransferase (AST)
Change from baseline in AST is reported.
Measured: Baseline, Day 92
Change From Baseline in Gamma-glutamyl Transferase (γGT)
Change from baseline in γGT is reported.
Measured: Baseline, Day 92
Change From Baseline in Alkaline Phosphatase
Change from baseline in alkaline phosphatase is reported.
Measured: Baseline, Day 92
Change From Baseline in Total Bilirubin
Change from baseline in total bilirubin is reported.
Measured: Baseline, Day 92
Maximum Plasma Concentration (Cmax) of FT-4101
Maximum plasma concentration (Cmax) of FT-4101 is reported
Measured: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days
Area Under the Concentration-time Curve for a Dosing Interval (AUCtau) of FT-4101
Measured: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days
Data for This Endpoint Was Not Collected and Analysed.
Measured: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201920 Jan 2020

First posted2 Jul 2019
Study start17 May 2019
Primary completion20 Jan 2020
Study completion20 Jan 2020

Why it stopped: sponsor decision

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 Nonalcoholic Steatohepatitis (NASH)Studies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04004325
Sponsor's protocol ID: 4101-MET-201
Status last verified: Oct 2025
First submitted: 10 Jun 2019
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Nonalcoholic Steatohepatitis (NASH) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH
ClinicalTrials.gov ID: NCT04004325
Acronym / sponsor ID: 4101-MET-201
Conditions: Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: sponsor decision
Enrolment: 14 participants (actual)
Lead sponsor: Forma Therapeutics, Inc.Industry (pharma, biotech, devices)
Collaborators: ProSciento, Inc.
Study start: 17 May 2019 (actual)
Primary completion: 20 Jan 2020 (actual)
Study completion: 20 Jan 2020 (actual)
First posted: 2 Jul 2019 (actual)
Results: Posted 21 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH.

The study may be conducted in up to 2 dosing cohorts.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Cohort A	Experimental	Drug: FT-4101, Drug: FT-4101 placebo, Other: Deuterated Water
Cohort B	Experimental	Drug: FT-4101, Drug: FT-4101 placebo, Other: Deuterated Water

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Meets all of the following criteria:
Body mass index (BMI) > 25.0 to < 45.0 kg/m2
Stable body weight
Subjects with T2DM may also be included, if:
Waist circumference ≤ 57 inches

Key exclusion criteria (26 listed)

Type 1 diabetes and type 2 diabetic subjects on insulin therapy
Diabetic complications, such as acute proliferative retinopathy
Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis
History of, or active, chronic liver disease due to alcohol, auto-immune, primary biliary cholangitis, HIV, HBV or active HCV-infection, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, etc., and not due to NASH disease
History of clinically significant or decompensated chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or MELD score ≥ 10.

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
FT-4101FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level.	Drug	Cohort A, Cohort B
FT-4101 placeboFT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.	Drug	Cohort A, Cohort B
Deuterated WaterDeuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%).	Other	Cohort A, Cohort B

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of study drug administration up to 20 weeks
TEAEs were defined as an adverse events (AEs) with an onset that occurred after receiving the first dose of the study drug (AE start date greater than or equal to [>=] first dose date) and within 30 days after receiving the last dose of the study drug (AE start date - last dose date less than or equal to [<=] 30). Number of participants with TEAEs are reported.
Number of Participants With Clinically Significant Changes in Laboratory Values
Time frame: Up to 20 weeks
Number of participants with clinically significant changes in laboratory values (hematology, serum chemistry, and urinalysis) are reported.
Number of Participants With Clinically Significant Changes in Physical Examination
Time frame: Up to 20 weeks
Number of participants with clinically significant changes in physical examination are reported.
Change From Baseline in Vital Signs: Blood Pressure (BP)
Time frame: Baseline, Day 92
Change from baseline in blood pressure (systolic and diastolic) are reported.
Change From Baseline in Vital Signs: Heart Rate (HR)
Time frame: Baseline, Day 92
Change from baseline in heart rate is reported.
Change From Baseline in Vital Signs: Respiratory Rate
Time frame: Baseline, Day 92
Change from baseline in respiratory rate is reported.
Change From Baseline in Vital Signs: Temperature
Time frame: Baseline, Day 92
Change from baseline in temperature is reported.
Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters: ECG Mean Heart Rate
Time frame: Baseline, Day 92
Change from baseline in ECG mean heart rate is reported.
Change From Baseline in 12-lead ECG Parameters: QT Interval
Time frame: Baseline, Day 92
Change from baseline in QT interval is reported.
Change From Baseline in 12-lead ECG Parameters: PR Interval
Time frame: Baseline, Day 92
Change from baseline in PR interval is reported.
Change From Baseline in 12-lead ECG Parameters: QRS Interval
Time frame: Baseline, Day 92
Change from baseline in QRS interval is reported.
Change From Baseline in 12-lead ECG Parameters: RR Interval
Time frame: Baseline, Day 92
Change from baseline in RR interval is reported.
Change From Baseline in 12-lead ECG Parameters: QTc (Corrected) Using the Fridericia Correction (QTcF) Interval
Time frame: Baseline, Day 92
Change from baseline in QTcF interval is reported.
Percent Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF)
Time frame: At week 12
Percent change from baseline in liver fat on MRI-PDFF is reported.
Change From Baseline in Liver Fat on Magnetic Resonance Imaging- Proton Density Fat Fraction (MRI-PDFF)
Time frame: At week 12
Change from baseline in percentage of liver fat on MRI-PDFF is reported.

11 secondary outcomes

Change From Baseline in Liver Fat on MRI-PDFF
Time frame: At week 6
Percent Change From Baseline in Liver Fat on MRI-PDFF
Time frame: At week 6
Percentage of Participants Experiencing a Relative Reduction of 30% or Greater of Liver Fat as Assessed by MRI-PDFF
Time frame: At week 12
Change From Baseline in Alanine Aminotransferase (ALT)
Time frame: Baseline, Day 92
Change From Baseline in Aspartate Aminotransferase (AST)
Time frame: Baseline, Day 92
Change From Baseline in Gamma-glutamyl Transferase (γGT)
Time frame: Baseline, Day 92
Change From Baseline in Alkaline Phosphatase
Time frame: Baseline, Day 92
Change From Baseline in Total Bilirubin
Time frame: Baseline, Day 92
Maximum Plasma Concentration (Cmax) of FT-4101
Time frame: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days
Area Under the Concentration-time Curve for a Dosing Interval (AUCtau) of FT-4101
Time frame: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days
Data for This Endpoint Was Not Collected and Analysed.
Time frame: Cycle 1 (Day 1), Cycle 4 (Day 14); each Cycle length = 21 days

Results and safety

Results posted to the registry on 21 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FT-4101 3.0 mg	9	9
Placebo	5	5

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: From start of study drug administration up to 20 weeks. Count of participants. Unit: Participants

Measure	FT-4101 3.0 mg n = 9	Placebo n = 5
Value	3	3

Population analysed: The Safety analysis set included all randomized participants who received investigational product (IP) (FT-4101 or placebo) or deuterated water.

Primary outcome: Number of Participants With Clinically Significant Changes in Laboratory Values

Time frame: Up to 20 weeks. Count of participants. Unit: Participants

Measure	FT-4101 3.0 mg n = 9	Placebo n = 5
Value	0	0

Population analysed: The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water.

Primary outcome: Number of Participants With Clinically Significant Changes in Physical Examination

Time frame: Up to 20 weeks. Count of participants. Unit: Participants

Measure	FT-4101 3.0 mg n = 9	Placebo n = 5
Value	0	0

Population analysed: The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water.

Primary outcome: Change From Baseline in Vital Signs: Blood Pressure (BP)

Time frame: Baseline, Day 92. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	FT-4101 3.0 mg n = 9	Placebo n = 5
Systolic BP	-0.2 (16.45)	-5.2 (8.44)
Diastolic BP	0.4 (14.93)	-2.4 (6.11)

Population analysed: The Safety analysis set included all randomized participants who received IP (FT-4101 or placebo) or deuterated water.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study drug administration up to 20 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FT-4101 3.0 mg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Placebo	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Limitations and caveats (from the sponsor): The study was planned for two dosing cohorts (Cohort A and Cohort B), but only Cohort A was included. The study terminated because of observed insufficient efficacy with the studied dose to warrant further investigation. The 3 mg dose didn't raise safety concerns, but to achieve a meaningful result, higher doses would exceed the safe limit based on past studies. Therefore, it was determined that further evaluation of FT-4101 dose escalations for the study indication was not appropriate.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Clinical Transparency (dept. 2834), MD study director

Novo Nordisk A/S

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FT-4101 and Deuterated Water in people with Nonalcoholic Steatohepatitis (NASH) and Overweight or Obesity, run by Forma Therapeutics, Inc. at 2 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 11 inclusion and 26 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

Yes. Results are posted in the registry (first posted 21 Nov 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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From start of study drug administration up to 20 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04004325.

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 20 Oct 2025.