NASH - Nonalcoholic SteatohepatitisPhase 2NCT03976401

A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

A Phase 2 study testing EFX in people with NASH - Nonalcoholic Steatohepatitis, run by Akero Therapeutics, Inc at 27 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: NASH - Nonalcoholic Steatohepatitis
What is being tested?: EFX
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 27 sitesin 2 countries
Study dates: 28 May 2019to 10 Jan 2022
Phase: Phase 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
Steatosis (scored 0 to 3),
Ballooning degeneration (scored 0 to 2), and

Show all 9Show fewer

Lobular inflammation (scored 0 to 3)
Cohort C only: FibroScan® measurement > 13.1 kPa.
Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.

Who cannot join

Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
Type 1 and insulin-dependent Type 2 diabetes.
Poorly controlled hypertension (blood pressure > 160/100).

Trial locations and contacts

27 sites in 2 countries.

Country

City, postcode or hospital

27 sites in 2 countries

United States26 sites

Akero Clinical Study Site
Baton Rouge, Louisiana, 70809
Akero Clinical Study Site
Berlin, New Jersey, 08009
Akero Clinical Study Site
Boca Raton, Florida, 33434
Akero Clinical Study Site
Cedar Park, Texas, 78613
Akero Clinical Study Site
Chattanooga, Tennessee, 37421
Akero Clinical Study Site
Dallas, Texas, 75246
Akero Clinical Study Site
Edinburg, Texas, 78539
Akero Clinical Study Site
Fort Worth, Texas, 76104
Akero Clinical Study Site
Huntington Park, California, 90255
Akero Clinical Study Site
Kansas City, Missouri, 64131
Akero Clinical Study Site
Lakewood Rch, Florida, 34211
Akero Clinical Study Site
Little Rock, Arkansas, 72117
Akero Clinical Study Site
Los Angeles, California, 90036
Akero Clinical Study Site
Los Angeles, California, 90057
Akero Clinical Study Site
Marrero, Louisiana, 70072
Akero Clinical Study Site
Miami, Florida, 33156
Akero Clinical Study Site
New Port Richey, Florida, 34653
Akero Clinical Study Site
Ocoee, Florida, 34761
Akero Clinical Study Site
Panorama City, California, 91402
Akero Clinical Study Site
Port Orange, Florida, 32127
Akero Clinical Study Site
Poway, California, 92064
Akero Clinical Study Site
San Antonio, Texas, 78215
Akero Clinical Study Site
San Antonio, Texas, 78229
Akero Clinical Study Site
Sarasota, Florida, 34240
Akero Clinical Study Site
Tucson, Arizona, 85711
Akero Clinical Study Site
Webster, Texas, 77598

Other trials in United States

Puerto Rico1 site

Akero Clinical Study Site
San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Nonalcoholic Steatohepatitis (NASH)

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.

Conditions: NASH - Nonalcoholic Steatohepatitis
Being tested: EFX, 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.

EFXDrug
Administered by subcutaneous injection
PlaceboDrug
Administered by subcutaneous injection

Study groups in NCT03976401
Study group	Role	What they receive
EFX Dose 1	Experimental	Main Study Receives: Drug: EFX
EFX Dose 2	Experimental	Main Study Receives: Drug: EFX
EFX Dose 3	Experimental	Main Study Receives: Drug: EFX
Placebo	Placebo comparator	Main Study Receives: Drug: Placebo
EFX Dose (Cohort C)	Experimental	Not described Receives: Drug: EFX
Placebo (Cohort C)	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Measured: 12 weeks

Secondary outcomes (9)

Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 22-24.
Main study. Included subjects with ≥30% relative fat reduction on MRI-PDFF at Week 12 that were required to return between Weeks 22 - 24. ANCOVA model with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction as a covariate were performed.
Measured: 22-24 weeks
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 12.
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Measured: 12 weeks
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 22-24.
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Measured: 22-24 weeks
Main: Responder: Subjects Who Achieved a Clinically Meaningful Relative Reduction of at Least 30% in Liver Fat Content as Measured by MRI-PDFF at Week 12.
Main Study. The analyses included the treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
Measured: 12 weeks
Main: Responder Based on NAFLD Activity Score System (NAS): Subjects Who Had a Decrease of ≥2 Points in NAS With at Least a 1-point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and With no Concurrent Worsening of Fibrosis Stage.
Main study: Responders were defined for subjects with ≥ 30% relative fat reduction on MRI-PDFF at Week 12 and required to return between Weeks 22 - 24. Fisher's exact test was used for the analysis using the Full Analysis Set with missing values imputed as non-responders and repeated on Liver Biopsy Evaluable Analysis Set without imputation.
Measured: 22-24 weeks
Main: Change From Baseline in ALT at Week 12, 16, and 20.
ANCOVA model with treatment group, baseline hepatic fat fraction (<15% vs ≥15%), and F1 fibrosis score (F1 vs F2-3) as factors and baseline value as a covariate.
Measured: 12, 16, and 20 weeks
Cohort C: Change From Baseline in Liver Stiffness as Evaluated by FibroScan at Week 16
Cohort C: ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set. Missing values at Week 16 were imputed using the last-observed-carried-forward (LOCF) method.
Measured: 16 weeks
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.
Cohort C. ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set. Missing values were imputed using the last-observed-carried-forward (LOCF) method.
Measured: 12, 16, and 20 weeks
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Liver Fibrosis by ELF Test Score at Week 12 and 16.
Cohort C. The enhanced liver fibrosis (ELF) score describes the severity of liver fibrosis where a score of <7.7 indicates no or mild fibrosis, a score of ≥7.7 to <9.8 indicates moderate fibrosis, and a score of ≥9.8 indicates severe fibrosis. A change from baseline with a negative value indicates a decrease in severity of liver fibrosis.
An ANCOVA model with treatment group as a factor and baseline liver stiffness as evaluated by FibroScan® as a covariate using the Full Analysis Set was used. Missing values were imputed using the last-observed-carried-forward (LOCF) method.
Measured: 12 and 16 weeks

Timeline

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

28 May 201910 Jan 2022

First posted6 Jun 2019
Study start28 May 2019
Primary completion10 Feb 2021
Study completion10 Jan 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.
Publications (3)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03976401
Sponsor's protocol ID: AK-US-001-0101
Status last verified: Aug 2022
First submitted: 3 Jun 2019
Last updated: 4 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
PubMed 39326675
Harrison SA, Ruane PJ, Freilich B, Neff G, Patil R, Behling C, Hu C, Shringarpure R, de Temple B, Fong E, Tillman EJ, Rolph T, Cheng A, Yale K. A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis. JHEP Rep. 2022 Aug 23;5(1):100563. doi: 10.1016/j.jhepr.2022.100563. eCollection 2023 Jan.
PubMed 36644237
Harrison SA, Ruane PJ, Freilich BL, Neff G, Patil R, Behling CA, Hu C, Fong E, de Temple B, Tillman EJ, Rolph TP, Cheng A, Yale K. Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial. Nat Med. 2021 Jul;27(7):1262-1271. doi: 10.1038/s41591-021-01425-3. Epub 2021 Jul 8.
PubMed 34239138

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?

See locations

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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
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A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
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Target of Suv420h1/2 in Hepatocytes
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A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)

All NASH - Nonalcoholic Steatohepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT03976401
Acronym / sponsor ID: AK-US-001-0101
Conditions: NASH - Nonalcoholic Steatohepatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Akero Therapeutics, IncIndustry (pharma, biotech, devices)
Study start: 28 May 2019 (actual)
Primary completion: 10 Feb 2021 (actual)
Study completion: 10 Jan 2022 (actual)
First posted: 6 Jun 2019 (actual)
Results: Posted 4 Aug 2022

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 multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
EFX Dose 1	Experimental	Drug: EFXMain Study
EFX Dose 2	Experimental	Drug: EFXMain Study
EFX Dose 3	Experimental	Drug: EFXMain Study
Placebo	Placebo comparator	Drug: PlaceboMain Study
EFX Dose (Cohort C)	Experimental	Drug: EFX
Placebo (Cohort C)	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).
Main Study only: Must have confirmation of ≥ 10% liver fat content on magnetic resonance imaging- proton density fat fraction (MRI-PDFF) at screening.
Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
Cohort C only: FibroScan® measurement > 13.1 kPa.

Key exclusion criteria (3 listed)

Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.
Type 1 and insulin-dependent Type 2 diabetes.
Poorly controlled hypertension (blood pressure > 160/100).

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
EFXAdministered by subcutaneous injection	Drug	EFX Dose (Cohort C), EFX Dose 1, EFX Dose 2, EFX Dose 3
PlaceboAdministered by subcutaneous injection	Drug	Placebo, Placebo (Cohort C)

Primary outcome

Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.
Time frame: 12 weeks
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.

9 secondary outcomes

Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 22-24.
Time frame: 22-24 weeks
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 12.
Time frame: 12 weeks
Main: Percent Change From Baseline in Hepatic Fat Fraction Measured by MRI-PDFF at Week 22-24.
Time frame: 22-24 weeks
Main: Responder: Subjects Who Achieved a Clinically Meaningful Relative Reduction of at Least 30% in Liver Fat Content as Measured by MRI-PDFF at Week 12.
Time frame: 12 weeks
Main: Responder Based on NAFLD Activity Score System (NAS): Subjects Who Had a Decrease of ≥2 Points in NAS With at Least a 1-point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and With no Concurrent Worsening of Fibrosis Stage.
Time frame: 22-24 weeks
Main: Change From Baseline in ALT at Week 12, 16, and 20.
Time frame: 12, 16, and 20 weeks
Cohort C: Change From Baseline in Liver Stiffness as Evaluated by FibroScan at Week 16
Time frame: 16 weeks
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Pro-C3 at Week 12, 16, and 20.
Time frame: 12, 16, and 20 weeks
Cohort C: Change From Baseline in Non-invasive Biomarkers Including Liver Fibrosis by ELF Test Score at Week 12 and 16.
Time frame: 12 and 16 weeks

Results and safety

Results posted to the registry on 4 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Study EFX 28 mg	19	16
Main Study EFX 50 mg	20	16
Main Study EFX 70 mg	20	15
Main Study Placebo	21	19
Cohort C EFX 50 mg	20	19
Cohort C Placebo	10	9

Primary outcome: Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12.

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Absolute percentage of hepatic fat

Measure	Main Study EFX 28 mg n = 19	Main Study EFX 50 mg n = 20	Main Study EFX 70 mg n = 20	Main Study Placebo n = 21
Value	-12.32 (1.04)	-13.44 (1.04)	-14.14 (1.04)	-0.29 (0.98)

Population analysed: Full Analysis Set (all randomized subjects)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 20-24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study EFX 28 mg	1 of 19 (5.3%)	18 of 19 (94.7%)	0 of 19
Main Study EFX 50 mg	0 of 19 (0%)	17 of 19 (89.5%)	0 of 19
Main Study EFX 70 mg	1 of 20 (5%)	19 of 20 (95%)	0 of 20
Main Study Placebo	0 of 21 (0%)	16 of 21 (76.2%)	0 of 21
Cohort C EFX 50 mg	0 of 20 (0%)	19 of 20 (95%)	0 of 20
Cohort C Placebo	1 of 10 (10%)	8 of 10 (80%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39326675Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
Derived from this study: PubMed 36644237Harrison SA, Ruane PJ, Freilich B, Neff G, Patil R, Behling C, Hu C, Shringarpure R, de Temple B, Fong E, Tillman EJ, Rolph T, Cheng A, Yale K. A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis. JHEP Rep. 2022 Aug 23;5(1):100563. doi: 10.1016/j.jhepr.2022.100563. eCollection 2023 Jan.
Derived from this study: PubMed 34239138Harrison SA, Ruane PJ, Freilich BL, Neff G, Patil R, Behling CA, Hu C, Fong E, de Temple B, Tillman EJ, Rolph TP, Cheng A, Yale K. Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial. Nat Med. 2021 Jul;27(7):1262-1271. doi: 10.1038/s41591-021-01425-3. Epub 2021 Jul 8.

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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.

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EFX in people with NASH - Nonalcoholic Steatohepatitis, run by Akero Therapeutics, Inc at 27 sites in 2 countries.

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 9 inclusion and 3 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 4 Aug 2022). 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?

Main: Absolute Change From Baseline in Hepatic Fat Fraction Assessed by MRI-PDFF at Week 12. (time frame: 12 weeks). 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 NCT03976401, which also lists 3 linked publications.

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 4 Aug 2022.