A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis (FORTUNA)

April 11, 2024 updated by: AstraZeneca

A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

Study Overview

Status

Recruiting

Conditions

Nonalcoholic Steatohepatitis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Caba, Argentina, C1119ACN
    - Recruiting
    - Research Site
  - Caba, Argentina, C1426
    - Recruiting
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1280
    - Recruiting
    - Research Site
  - Cordoba, Argentina, X5016
    - Withdrawn
    - Research Site
  - Cordoba, Argentina, X5000EPU
    - Not yet recruiting
    - Research Site
  - Cordoba, Argentina, X5014PQC
    - Withdrawn
    - Research Site
  - Florencio Varela, Argentina, 1888
    - Recruiting
    - Research Site
  - La Plata, Argentina, 1900
    - Recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GNY
    - Recruiting
    - Research Site
  - Ramos Mejía, Argentina, B1704ETD
    - Withdrawn
    - Research Site
Brazil
- - Belo Horizonte, Brazil, 30130-090
    - Not yet recruiting
    - Research Site
  - Botucatu, Brazil, 18618-687
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-000
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 21941-913
    - Not yet recruiting
    - Research Site
  - Salvador, Brazil, 40110-160
    - Recruiting
    - Research Site
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Recruiting
    - Research Site
  - Sao Paulo, Brazil, 05403-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04023-062
    - Withdrawn
    - Research Site
Chile
- - Santiago, Chile
    - Recruiting
    - Research Site
  - Santiago, Chile, 8330336
    - Withdrawn
    - Research Site
  - Santiago, Chile, 7620157
    - Recruiting
    - Research Site
  - Valdivia, Chile, 5110683
    - Recruiting
    - Research Site
China
- - Baotou, China, 014010
    - Recruiting
    - Research Site
  - Beijing, China, 100044
    - Recruiting
    - Research Site
  - Beijing, China, 100069
    - Recruiting
    - Research Site
  - Beijing, China, 100057
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Fuzhou, China, 350005
    - Recruiting
    - Research Site
  - Fuzhou, China, 350005
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Guangzhou, China, 510515
    - Recruiting
    - Research Site
  - Hangzhou, China, 310003
    - Recruiting
    - Research Site
  - Liaocheng, China, 252000
    - Recruiting
    - Research Site
  - Nanchang, China, 330000
    - Recruiting
    - Research Site
  - Qingdao, China, 266011
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200080
    - Recruiting
    - Research Site
  - Shanghai, China, 200092
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Taiyuan, China, 030001
    - Recruiting
    - Research Site
  - Tianjin, China, 300091
    - Withdrawn
    - Research Site
  - Wenzhou, China, 325000
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Recruiting
    - Research Site
  - Zhenjiang, China, 212021
    - Recruiting
    - Research Site
Colombia
- - Armenia, Colombia, 630004
    - Not yet recruiting
    - Research Site
  - Barranquilla, Colombia, 080020
    - Not yet recruiting
    - Research Site
  - Bogota, Colombia, 110221
    - Not yet recruiting
    - Research Site
  - Cartagena, Colombia, 130013
    - Not yet recruiting
    - Research Site
Germany
- - Konstanz, Germany, 78464
    - Recruiting
    - Research Site
  - Magdeburg, Germany
    - Recruiting
    - Research Site
  - Mainz, Germany, 55131
    - Recruiting
    - Research Site
  - Mannheim, Germany, 68167
    - Withdrawn
    - Research Site
  - Münster, Germany, 48149
    - Recruiting
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Research Site
  - Shatin, Hong Kong
    - Recruiting
    - Research Site
India
- - Belagavi, India, 590010
    - Withdrawn
    - Research Site
  - Chandigarh, India, 160012
    - Not yet recruiting
    - Research Site
  - Gurugram, India, 122001
    - Withdrawn
    - Research Site
  - Hyderabad, India, 500072
    - Recruiting
    - Research Site
  - Jaipur, India, 302001
    - Recruiting
    - Research Site
  - Jaipur, India, 302018
    - Recruiting
    - Research Site
  - Jodhpur, India, 342005
    - Withdrawn
    - Research Site
  - Kolkata, India, 700020
    - Not yet recruiting
    - Research Site
  - Luknow, India, 226003
    - Not yet recruiting
    - Research Site
  - Nagpur, India, 440010
    - Withdrawn
    - Research Site
  - Punjab, India, 160062
    - Recruiting
    - Research Site
  - Rajkot, India, 360004
    - Recruiting
    - Research Site
  - Surat, India, 395009
    - Recruiting
    - Research Site
Italy
- - Milano, Italy, 20122
    - Recruiting
    - Research Site
  - Palermo, Italy, 90127
    - Recruiting
    - Research Site
  - Roma, Italy, 00128
    - Recruiting
    - Research Site
  - Rome, Italy, 00168
    - Recruiting
    - Research Site
  - Torino, Italy, 10126
    - Recruiting
    - Research Site
Japan
- - Bunkyo-ku, Japan, 113-8655
    - Recruiting
    - Research Site
  - Fukui-shi, Japan, 918-8503
    - Recruiting
    - Research Site
  - Fukuoka-Shi, Japan, 812-8582
    - Withdrawn
    - Research Site
  - Fukuoka-shi, Japan, 810-0065
    - Recruiting
    - Research Site
  - Gifu-shi, Japan, 500-8513
    - Recruiting
    - Research Site
  - Kagoshima-shi, Japan, 890-8520
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Withdrawn
    - Research Site
  - Kawasaki-shi, Japan, 215-0026
    - Recruiting
    - Research Site
  - Kobe-shi, Japan, 650-0017
    - Recruiting
    - Research Site
  - Kobe-shi, Japan, 650-0047
    - Withdrawn
    - Research Site
  - Kumamoto-shi, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kure-shi, Japan, 737-0023
    - Recruiting
    - Research Site
  - Kurume-shi, Japan, 830-0011
    - Recruiting
    - Research Site
  - Kyoto-shi, Japan, 602-8566
    - Recruiting
    - Research Site
  - Meguro-ku, Japan, 152-8902
    - Withdrawn
    - Research Site
  - Minato-ku, Japan, 105-8470
    - Recruiting
    - Research Site
  - Nagakute-shi, Japan, 480-1195
    - Withdrawn
    - Research Site
  - Nagoya-shi, Japan, 460-0001
    - Recruiting
    - Research Site
  - Ogaki-shi, Japan, 503-8502
    - Withdrawn
    - Research Site
  - Oita-shi, Japan, 870-0837
    - Recruiting
    - Research Site
  - Okayama-shi, Japan, 700-8505
    - Recruiting
    - Research Site
  - Omura-shi, Japan, 856-8562
    - Recruiting
    - Research Site
  - Osaka, Japan, 545-8586
    - Recruiting
    - Research Site
  - Saga-shi, Japan, 849-8501
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - Recruiting
    - Research Site
  - Shinjuku-ku, Japan, 160-0023
    - Recruiting
    - Research Site
  - Suita-shi, Japan, 564-0013
    - Withdrawn
    - Research Site
  - Takasaki-shi, Japan, 370-0829
    - Recruiting
    - Research Site
  - Tsu-shi, Japan, 514-8507
    - Recruiting
    - Research Site
  - Wako-shi, Japan, 351-0102
    - Recruiting
    - Research Site
  - Yokohama-shi, Japan, 236-0004
    - Recruiting
    - Research Site
  - Yokohama-shi, Japan, 245-8575
    - Recruiting
    - Research Site
Korea, Republic of
- - Jung-gu, Korea, Republic of, 41944
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03722
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Research Site
  - Seoul, Korea, Republic of, 04763
    - Recruiting
    - Research Site
Malaysia
- - Kota Kinabalu, Malaysia, 88586
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 56000
    - Recruiting
    - Research Site
  - Pulau Pinang, Malaysia, 10450
    - Recruiting
    - Research Site
  - Seremban, Malaysia, 70300
    - Recruiting
    - Research Site
Mexico
- - Acapulco, Mexico, 39670
    - Recruiting
    - Research Site
  - Ciudad de Mexico, Mexico, 06700
    - Recruiting
    - Research Site
  - Cuernavaca, Mexico, 62250
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44130
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44670
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44340
    - Recruiting
    - Research Site
  - Mexico City, Mexico, 03310
    - Not yet recruiting
    - Research Site
  - Mexico City, Mexico, 03330
    - Recruiting
    - Research Site
  - Mexico D.F., Mexico, 014080
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64000
    - Withdrawn
    - Research Site
  - México, Mexico, 06726
    - Not yet recruiting
    - Research Site
  - Tlalpan, Mexico, 14050
    - Not yet recruiting
    - Research Site
  - Torreon, Mexico, 27000
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91851
    - Recruiting
    - Research Site
  - Xalapa, Mexico, 91020
    - Recruiting
    - Research Site
Peru
- - Chorrillos, Peru, Lima 9
    - Recruiting
    - Research Site
  - Lima, Peru, 15023
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15036
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15046
    - Not yet recruiting
    - Research Site
Philippines
- - Cebu, Philippines, 6000
    - Recruiting
    - Research Site
  - Puerto Princesa City, Philippines, 5300
    - Recruiting
    - Research Site
  - Roxas City, Philippines, 5800
    - Recruiting
    - Research Site
  - San Fernando, Philippines, 2000
    - Recruiting
    - Research Site
Portugal
- - Lisboa, Portugal, 1250-189
    - Withdrawn
    - Research Site
  - Vila Real, Portugal, 5000-508
    - Withdrawn
    - Research Site
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - Research Site
  - Singapore, Singapore, 119074
    - Recruiting
    - Research Site
  - Singapore, Singapore, 169608
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15006
    - Recruiting
    - Research Site
  - Almeria, Spain, 4009
    - Recruiting
    - Research Site
  - Lérida, Spain, 25198
    - Recruiting
    - Research Site
  - Malaga, Spain, 29010
    - Recruiting
    - Research Site
  - Zaragoza, Spain, 50009
    - Recruiting
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 80756
    - Recruiting
    - Research Site
  - Tainan City, Taiwan, 70403
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
Turkey
- - Adana, Turkey, 01060
    - Recruiting
    - Research Site
  - Antalya, Turkey, 07059
    - Recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Recruiting
    - Research Site
  - Eskisehir, Turkey, 26480
    - Recruiting
    - Research Site
  - Izmir, Turkey, 35340
    - Recruiting
    - Research Site
  - Rize, Turkey, 530020
    - Recruiting
    - Research Site
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Research Site
  - Flagstaff, Arizona, United States, 86001
    - Not yet recruiting
    - Research Site
  - Peoria, Arizona, United States, 85381
    - Recruiting
    - Research Site
  - Surprise, Arizona, United States, 85378
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85715
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85712
    - Recruiting
    - Research Site
- California
  - Canoga Park, California, United States, 91303
    - Withdrawn
    - Research Site
  - Gardena, California, United States, 90247
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92037
    - Not yet recruiting
    - Research Site
  - La Mesa, California, United States, 91942
    - Recruiting
    - Research Site
  - Lancaster, California, United States, 93534
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90057
    - Recruiting
    - Research Site
  - Montclair, California, United States, 91763
    - Recruiting
    - Research Site
  - Orange, California, United States, 92868
    - Recruiting
    - Research Site
  - Rialto, California, United States, 92377
    - Recruiting
    - Research Site
  - Santa Ana, California, United States, 92704
    - Recruiting
    - Research Site
  - Santa Maria, California, United States, 93458
    - Not yet recruiting
    - Research Site
- Colorado
  - Englewood, Colorado, United States, 80113
    - Recruiting
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33434
    - Recruiting
    - Research Site
  - Hialeah, Florida, United States, 33016
    - Recruiting
    - Research Site
  - Jacksonville, Florida, United States, 32216
    - Recruiting
    - Research Site
  - Port Orange, Florida, United States, 32127
    - Recruiting
    - Research Site
  - Winter Park, Florida, United States, 32792
    - Recruiting
    - Research Site
- Georgia
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Research Site
- Kansas
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - Research Site
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64131
    - Withdrawn
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Withdrawn
    - Research Site
  - Las Vegas, Nevada, United States, 89101
    - Recruiting
    - Research Site
- New York
  - Buffalo, New York, United States, 14203
    - Recruiting
    - Research Site
- Ohio
  - Westlake, Ohio, United States, 44145
    - Recruiting
    - Research Site
- Oklahoma
  - Chickasha, Oklahoma, United States, 73018
    - Recruiting
    - Research Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Not yet recruiting
    - Research Site
- South Carolina
  - Summerville, South Carolina, United States, 29485
    - Recruiting
    - Research Site
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Recruiting
    - Research Site
- Texas
  - Austin, Texas, United States, 78745
    - Withdrawn
    - Research Site
  - Austin, Texas, United States, 78757
    - Recruiting
    - Research Site
  - Brownsville, Texas, United States, 78520
    - Recruiting
    - Research Site
  - Denison, Texas, United States, 75020
    - Recruiting
    - Research Site
  - Edinburg, Texas, United States, 78539
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77030
    - Recruiting
    - Research Site
  - Red Oak, Texas, United States, 75154
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Withdrawn
    - Research Site
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - Research Site
- Virginia
  - Richmond, Virginia, United States, 23249
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Research Site
Vietnam
- - Ho Chi Minh, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Ho Chi Minh, Vietnam, 70000
    - Withdrawn
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria :

Participants are eligible to be included in the study only if all the following criteria apply:

Age

Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:
1. Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
1. Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.

Key Exclusion Criteria :

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

Liver disease of other aetiologies (eg, alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease)
History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
Historical persistent or pre-existing renal disease marked by eGFR < 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
Confirmed platelet count outside the normal range at the screening visit.
Any of the following confirmed at the screening visit:
1. ALT > 5.0 × ULN
2. TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN)
3. INR > 1.3
4. ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Participants in this arm will receive placebo	Other: Placebo Sodium chloride 0.9% solution SC once per month
Experimental: AZD2693 dose 1 Participants will receive AZD2693 dose 1	Drug: AZD2693 AZD2693 solution SC once per month
Experimental: AZD2693 dose 2 Participants will receive AZD2693 dose 2	Drug: AZD2693 AZD2693 solution SC once per month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment Time Frame: after 52 weeks	To assess the effect of AZD2693 versus placebo on histological resolution of NASH in participants with non-cirrhotic NASH with fibrosis and PNPLA3 risk allele carriers after 52 weeks	after 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment Time Frame: after 52 weeks	To assess the effects of AZD2693 versus placebo on histological fibrosis improvement	after 52 weeks
Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment Time Frame: after 52 weeks	To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS	after 52 weeks
Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment Time Frame: after 52 weeks	To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage	after 52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results Time Frame: 64 weeks	Haematology, urinalysis, clinical chemistry and eGFR	64 weeks
Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results Time Frame: 64 weeks	Vital signs and electrocardiogram (ECG) assessments	64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

AstraZeneca K.K.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

November 7, 2025

Study Completion (Estimated)

November 7, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D7830C00004
2022-001629-65 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nonalcoholic Steatohepatitis

Duke University

Completed

Feasibility of VIIT in Adults With NASH

Liver Diseases | Nonalcoholic Steatohepatitis (NASH) | Nonalcoholic Steatohepatitis | Nonalcoholic Fatty Liver

United States
Gilead Sciences

Completed

Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis (NASH) | Nonalcoholic Fatty Liver Disease (NAFLD)

United States, New Zealand
National Institute of Diabetes and Digestive and...

Completed

The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) (FLINT)

Nonalcoholic Steatohepatitis (NASH) | Nonalcoholic Fatty Liver Disease (NAFLD)

United States
Polaris Group

Recruiting

Study of ADI-PEG 20 Versus Placebo in Subjects With NASH

Nonalcoholic Steatohepatitis (NASH)

Taiwan
Corcept Therapeutics

Recruiting

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis (NASH)

United States
Perspectum

Recruiting

Non-Invasive Quantification of Liver Health in NASH (N-QUAN)

NASH - Nonalcoholic Steatohepatitis

United States
Metacrine, Inc.

Completed

Study to Evaluate MET642 in Patients With NASH

NASH - Nonalcoholic Steatohepatitis

United States
Cascade Pharmaceuticals, Inc
Laboratory Corporation of America

Completed

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH

Nonalcoholic Steatohepatitis (NASH)

United States
Poxel SA

Completed

Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)

NASH - Nonalcoholic Steatohepatitis

United States
RWTH Aachen University

Completed

Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health" (ADLH)

NASH - Nonalcoholic Steatohepatitis

Sweden, Austria, Germany

Clinical Trials on AZD2693

AstraZeneca

Recruiting

A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693

Hepatic Impairment

United States
AstraZeneca
Parexel

Completed

A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects

Metabolic Disorders | Non-alcoholic Steatohepatitis

United States
AstraZeneca
Parexel

Completed

A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients

Non-alcoholic Steatohepatitis (NASH)

United States
AstraZeneca

Completed

Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants

Healthy Participants

Japan

A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis (FORTUNA)

A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele

Study Overview

Status

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Contacts and Locations

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Accepts Healthy Volunteers

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What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

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Study Completion (Estimated)

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First Submitted That Met QC Criteria

First Posted (Actual)

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Last Update Submitted That Met QC Criteria

Last Verified

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