Nonalcoholic Fatty LiverPhase 2NCT03763877

A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

A Phase 2 study testing PXL770 in people with Nonalcoholic Fatty Liver, run by Poxel SA at 15 sites in United States.

Completed

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

Trial summary

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nonalcoholic Fatty Liver
What is being tested?: PXL770
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 15 sitesUnited States
Study dates: 29 Mar 2019to 10 Aug 2020
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients have given written informed consent
Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²
For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]
Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males
Hepatic steatosis (MRI-PDFF ≥ 10%)
Effective contraception for women of child bearing potential

Who cannot join

Evidence of another form of liver disease
Evidence of liver cirrhosis
Evidence of hepatic impairment
Positive serologic evidence of current infectious liver disease
History of excessive alcohol intake
Acute cardiovascular disease with 24 weeks prior to screening

Show all 10Show fewer

Uncontrolled high blood pressure
Any disease which in the Investigator's opinion which in the Investigator's opinion would exclude the patient from the study
Use of non-permitted concomitant medication
Pregnancy or lactation

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study Site 06
Arlington, Texas, 76012
Study Site 10
Athens, Georgia, 30607
Study Site 08
Berlin, New Jersey, 08009
Study Site 09
Durham, North Carolina, 27710
Study Site 01
Gainesville, Florida, 32610
Study Site 03
Indianapolis, Indiana, 46260
Study Site 02
Los Angeles, California, 90057
Study Site 07
Marrero, Louisiana, 70072
Study Site 11
Ocoee, Florida, 34761
Study Site 15
Orlando, Florida, 32804
Study Site 13
Rapid City, South Dakota, 57701
Study Site 14
Richmond, Virginia, 23294
Study Site 04
San Antonio, Texas, 78207
Study Site 12
San Antonio, Texas, 78215
Study Site 05
West Monroe, Louisiana, 71291

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

Read the detailed description

The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).

Conditions: Nonalcoholic Fatty Liver
Being tested: PXL770, Placebo Oral Capsule
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.

PXL770Drug
Oral capsule
Placebo Oral CapsuleDrug
Oral capsule

Study groups in NCT03763877
Study group	Role	What they receive
Group 1	Experimental	PXL770 Dose 1 Receives: Drug: PXL770
Group 2	Experimental	PXL770 Dose 2 Receives: Drug: PXL770
Group 3	Experimental	PXL770 Dose 3 Receives: Drug: PXL770
Group 4	Placebo comparator	Placebo oral capsule Receives: Drug: Placebo Oral Capsule

What is being measured

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

Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Measured: Baseline to Week 12
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Measured: Baseline to Week 12
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Measured: Baseline to Week 12
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Measured: Baseline to Week 12

Secondary outcomes (12)

Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Measured: Baseline to Week 12
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment
Responders were defined as patients who achieved a clinically meaningful relative reduction of at least 30% in liver fat mass From baseline to Week 12/EOT as assessed by MRI-PDFF
Measured: Baseline to Week 12
Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Total Cholesterol From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Triglycerides From Baseline to Week12/End of Treatment
Blood samples were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment
Fib-4 score is a non invasive method based on clinical determinations that indicates the level of fibrosis/ scarring of the liver. The set cutoffs for this scoring are: Fib-4 < 1.45: absence of cirrhosis; Fib-4 between 1.45 - 3.25: inconclusive and Fib-4 > 3.25: cirrhosis.
Fib-4 score was calculated as (Age [years] × AST [U/L]) / (platelet [10^9/L] × √[ALT [U/L]]). Blood samples used for AST, ALT and platelet counts were collected, handled and stored according to the instructions described in the laboratory manual and all measurements were performed at a central laboratory.
Measured: Baseline to Week 12
Change in Body Weight From Baseline to Week 12/End of Treatment
Body weight was measured using a scale with appropriate resolution, placed on a stable, flat surface. Shoes, bulky layers of clothing, and jackets had to be removed so that only light clothing remained.
Measured: Baseline to Week 12

Timeline

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

29 Mar 201910 Aug 2020

First posted4 Dec 2018
Study start29 Mar 2019
Primary completion3 Aug 2020
Study completion10 Aug 2020

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 (1)Papers the sponsor has linked to this study.
Other trials for Nonalcoholic Fatty LiverStudies 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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03763877
Sponsor's protocol ID: PXL770-004
Status last verified: Oct 2021
First submitted: 28 Nov 2018
Last updated: 28 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Cusi K, Alkhouri N, Harrison SA, Fouqueray P, Moller DE, Hallakou-Bozec S, Bolze S, Grouin JM, Jeannin Megnien S, Dubourg J, Ratziu V. Efficacy and safety of PXL770, a direct AMP kinase activator, for the treatment of non-alcoholic fatty liver disease (STAMP-NAFLD): a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):889-902. doi: 10.1016/S2468-1253(21)00300-9. Epub 2021 Sep 22.
PubMed 34560015

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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All Nonalcoholic Fatty Liver trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
ClinicalTrials.gov ID: NCT03763877
Acronym / sponsor ID: PXL770-004
Conditions: Nonalcoholic Fatty Liver
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Poxel SAIndustry (pharma, biotech, devices)
Study start: 29 Mar 2019 (actual)
Primary completion: 3 Aug 2020 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 4 Dec 2018 (actual)
Results: Posted 28 Oct 2021

Clinical summary

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

This study will assess the efficacy and safety of 3 doses of PXL770 versus placebo after 12 weeks of treatment.

Detailed description

The study will be performed in patients with Nonalcoholic Fatty Liver Disease. The primary endpoint will be the assessment of the change in the percentage of liver fat mass (assessed by MRI-PDFF).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Drug: PXL770PXL770 Dose 1
Group 2	Experimental	Drug: PXL770PXL770 Dose 2
Group 3	Experimental	Drug: PXL770PXL770 Dose 3
Group 4	Placebo comparator	Drug: Placebo Oral CapsulePlacebo oral capsule

Who may qualify

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

Key inclusion criteria (7 listed)

Patients have given written informed consent
Body mass index (BMI) ≥ 25 to ≤ 50 kg/m²
For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or under stable oral glucose lowering drug
Estimated glomerular filtration rate (eGFR) ≥ 60 mL/[min*1.73m²]
Alanine amino transferase (ALT) > 20 IU/L in females and > 30 IU/L in males

Key exclusion criteria (10 listed)

Evidence of another form of liver disease
Evidence of liver cirrhosis
Evidence of hepatic impairment
Positive serologic evidence of current infectious liver disease
History of excessive alcohol intake

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
PXL770Oral capsule	Drug	Group 1, Group 2, Group 3
Placebo Oral CapsuleOral capsule	Drug	Group 4

Primary outcome

Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)
Time frame: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 region of interest (ROI) was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)
Time frame: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)
Time frame: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.
Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])
Time frame: Baseline to Week 12
MRI acquisitions were performed at pre-qualified local MRI facilities using qualified and standardized instruments at high field strength (3 T or 1.5T) without oral or intravenous contrast. All acquisitions images were transferred to a central reader vendor for central calculation and measurement of MRI-PDFF using the method of Zhong et al. to estimate water and fat components. A 3 cm2 ROI was placed in each Couinaud segment. Central reading was masked to treatment group, clinical data, study site of origin and timepoint.

12 secondary outcomes

Absolute Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment
Time frame: Baseline to Week 12
Percentage of Responders (Relative Reduction of at Least 30% in Liver Fat Mass) at Week 12/End of Treatment
Time frame: Baseline to Week 12
Change in Alanine Amino Transferase (ALT) From Baseline to Week 12/End of Treatment
Time frame: Baseline to Week 12
Change in Aspartate Amino Transferase (AST) From Baseline to Week 12/End of Treatment
Time frame: Baseline to Week 12
Change in Fasting Plasma Glucose (FPG) From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in Glycated Hemoglobin (HbA1c) From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in Total Cholesterol From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in High Density Lipoprotein-Cholesterol (HDL-C) From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in Triglycerides From Baseline to Week12/End of Treatment
Time frame: Baseline to Week 12
Change in Fibrosis-4 (Fib-4) Score From Baseline to Week 12/End of Treatment
Time frame: Baseline to Week 12
Change in Body Weight From Baseline to Week 12/End of Treatment
Time frame: Baseline to Week 12

Results and safety

Results posted to the registry on 28 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	31	26
PXL770 250 mg QD	30	26
PXL770 250 mg BID	31	24
PXL770 500 mg QD	29	24

Primary outcome: Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT)

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: percentage

Measure	Placebo n = 31	PXL770 250 mg QD n = 30	PXL770 250 mg BID n = 30	PXL770 500 mg QD n = 29
Value	-1.14 (6.344)	-1.03 (6.764)	-14.28 (6.697)	-14.68 (6.452)

Placebo vs PXL770 250 mg QD: Mean Difference (Final Values): 0.12 (95% CI -15.42 to 15.66), p = 0.9883, ANCOVA
Placebo vs PXL770 250 mg BID: Mean Difference (Final Values): -13.14 (95% CI -28.06 to 1.78), p = 0.0842, ANCOVA
Placebo vs PXL770 500 mg QD: Mean Difference (Final Values): -13.54 (95% CI -28.51 to 1.43), p = 0.0763, ANCOVA

Population analysed: Intent-to-treat set (ITTS), defined as all as-randomized patients who received at least one dose of study treatment.

Primary outcome: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Per Protocol Sensitivity Analysis)

Time frame: Baseline to Week 12. Least squares mean (Standard Error). Unit: percentage

Measure	Placebo n = 26	PXL770 250 mg QD n = 25	PXL770 250 mg BID n = 23	PXL770 500 mg QD n = 23
Value	-0.69 (5.818)	-2.27 (6.036)	-13.94 (6.232)	-18.00 (6.012)

Placebo vs PXL770 250 mg QD: Mean Difference (Final Values): -1.58 (95% CI -16.01 to 12.85), p = 0.8283, ANCOVA
Placebo vs PXL770 250 mg BID: Mean Difference (Final Values): -13.25 (95% CI -27.60 to 1.10), p = 0.0698, ANCOVA
Placebo vs PXL770 500 mg QD: Mean Difference (Final Values): -17.31 (95% CI -31.63 to -2.99), p = 0.0184, ANCOVA

Population analysed: Per Protocol Set (PPS), defined as all patients in the ITTS who complete the double-blind treatment period and have an overall treatment duration ≥8 weeks (≥56 days) without any CSR reportable protocol deviations (PD) that is deemed to affect the primary efficacy endpoint of MRI-PDFF.

Primary outcome: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Unstratified Wilcoxon Sensitivity Analysis)

Time frame: Baseline to Week 12. Median (Inter-Quartile Range). Unit: percentage

Measure	Placebo n = 31	PXL770 250 mg QD n = 30	PXL770 250 mg BID n = 30	PXL770 500 mg QD n = 29
Value	0.49 (-8.68 to 15.46)	1.44 (-17.85 to 9.31)	-8.32 (-28.91 to 7.29)	-15.29 (-35.87 to 7.06)

Placebo vs PXL770 250 mg QD: Location Shift: -4.22 (95% CI -15.64 to 8.65), p = 0.5537, Wilcoxon (Mann-Whitney)
Placebo vs PXL770 250 mg BID: Location Shift: -13.64 (95% CI -26.19 to 1.88), p = 0.1005, Wilcoxon (Mann-Whitney)
Placebo vs PXL770 500 mg QD: Location Shift: -18.72 (95% CI -31.95 to -1.58), p = 0.0387, Wilcoxon (Mann-Whitney)

Population analysed: ITTS, defined as all as-randomized patients who received at least one dose of study treatment.

Primary outcome: Relative Change in the Percentage of Liver Fat Mass (Assessed by MRI-PDFF) From Baseline to Week 12/End of Treatment (Subgroup Analysis - Type 2 Diabetes Mellitus [T2DM])

Time frame: Baseline to Week 12. Least squares mean (Standard Deviation). Unit: percentage

Measure	Placebo n = 14	PXL770 250 mg QD n = 13	PXL770 250 mg BID n = 14	PXL770 500 mg QD n = 12
Value	-6.11 (9.745)	1.15 (9.266)	-16.71 (8.997)	-27.24 (9.572)

Placebo vs PXL770 250 mg QD: Mean Difference (Final Values): 7.25 (95% CI -18.00 to 32.51), p = 0.5733, ANCOVA
Placebo vs PXL770 250 mg BID: Mean Difference (Final Values): -10.61 (95% CI -34.60 to 13.38), p = 0.3861, ANCOVA
Placebo vs PXL770 500 mg QD: Mean Difference (Final Values): -21.13 (95% CI -46.46 to 4.19), p = 0.1019, ANCOVA

Population analysed: ITTS T2DM subgroup, defined as all as-randomized T2DM patients who received at least one dose of study treatment.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were collected from the time of ICF signature to the End-of-study Visit, ie 19 weeks on average. Only events that occur after the first dose intake of IMP of the Double-blind (DB) treatment period or if they were present prior to the first intake of IMP of the DB treatment period and increased in severity or relationship to IMP after the first intake of IMP of the DB treatment period were considered as Treatment Emergent Adverse Events (TEAEs). Only TEAEs are presented in this section.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 31 (0%)	8 of 31 (25.8%)	0 of 31
PXL770 250 mg QD	0 of 30 (0%)	13 of 30 (43.3%)	0 of 30
PXL770 250 mg BID	2 of 30 (6.7%)	14 of 30 (46.7%)	0 of 30
PXL770 500 mg QD	1 of 29 (3.4%)	13 of 29 (44.8%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34560015Cusi K, Alkhouri N, Harrison SA, Fouqueray P, Moller DE, Hallakou-Bozec S, Bolze S, Grouin JM, Jeannin Megnien S, Dubourg J, Ratziu V. Efficacy and safety of PXL770, a direct AMP kinase activator, for the treatment of non-alcoholic fatty liver disease (STAMP-NAFLD): a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Gastroenterol Hepatol. 2021 Nov;6(11):889-902. doi: 10.1016/S2468-1253(21)00300-9. Epub 2021 Sep 22.
Related InfoLink provided by the sponsor.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PXL770 in people with Nonalcoholic Fatty Liver, run by Poxel SA at 15 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 7 inclusion and 10 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 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 28 Oct 2021). 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?

Relative Change in the Percentage of Liver Fat Mass (Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction [MRI-PDFF]) From Baseline to Week 12/End of Treatment (EOT) (time frame: Baseline to Week 12). The study lists 4 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 NCT03763877, which also lists 1 linked publication.

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 28 Oct 2021.