Nonalcoholic SteatohepatitisPhase 2FORTUNANCT05809934
A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Phase 2 study testing AZD2693 in people with Nonalcoholic Steatohepatitis, run by AstraZeneca at 163 sites in 22 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- AZD2693
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 163 sitesin 22 countries
- Study dates
- 15 Mar 2023to 29 Sep 2025
- 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
- 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:
Show all 9Show fewer
- Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
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- Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
Who cannot join
- 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.
Show all 11Show fewer
- Any of the following confirmed at the screening visit:
- ALT > 5.0 × ULN
- TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN)
- INR > 1.3
- ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)
Trial locations and contacts
163 sites in 22 countries.
163 sites in 22 countries
United States36 sites
Research Site
Austin, Texas, 78757
Research Site
Boca Raton, Florida, 33434
Research Site
Brownsville, Texas, 78520
Research Site
Chandler, Arizona, 85224
Research Site
Chickasha, Oklahoma, 73018
Research Site
Cordova, Tennessee, 38018
Research Site
Denison, Texas, 75020
Research Site
DeSoto, Texas, 75115
Research Site
Detroit, Michigan, 48202
Research Site
Edinburg, Texas, 78539
Research Site
Gardena, California, 90247
Research Site
Hershey, Pennsylvania, 17033
Research Site
Hialeah, Florida, 33016
Research Site
Jacksonville, Florida, 32216
Research Site
La Mesa, California, 91942
Research Site
Lancaster, California, 93534
Research Site
Las Vegas, Nevada, 89101
Research Site
Los Angeles, California, 90017
Research Site
Marietta, Georgia, 30060
Research Site
Montclair, California, 91763
Research Site
Orange, California, 92868
Research Site
Peoria, Arizona, 85381
Research Site
Port Orange, Florida, 32127
Research Site
Rialto, California, 92377
Research Site
Richmond, Virginia, 23249
Research Site
San Antonio, Texas, 78229
Research Site
Santa Ana, California, 92704
Research Site
Seattle, Washington, 98105
Research Site
Sugar Land, Texas, 77478
Research Site
Summerville, South Carolina, 29485
Research Site
Surprise, Arizona, 85378
Research Site
Topeka, Kansas, 66606
Research Site
Tucson, Arizona, 85712
Research Site
Tucson, Arizona, 85715
Research Site
Westlake, Ohio, 44145
Research Site
Winter Park, Florida, 32792
Japan25 sites
Research Site
Bunkyō City, 113-8655
Research Site
Fukui-shi, 918-8503
Research Site
Fukuoka, 810-0065
Research Site
Gifu, 500-8513
Research Site
Kagoshima, 890-8520
Research Site
Kawasaki-shi, 215-0026
Research Site
Kobe, 650-0017
Research Site
Kumamoto, 860-8556
Research Site
Kure-shi, 737-0023
Research Site
Kurume-shi, 830-0011
Research Site
Kyoto, 602-8566
Research Site
Minatoku, 105-8470
Research Site
Nagoya, 460-0001
Research Site
Ōita, 870-0837
Research Site
Okayama, 700-8505
Research Site
Omura-shi, 856-8562
Research Site
Osaka, 545-8586
Research Site
Saga, 849-8501
Research Site
Shinjuku-ku, 160-0023
Research Site
Shinjuku-ku, 160-8582
Research Site
Shinjuku-ku, 162-8655
Research Site
Takasaki-shi, 370-0829
Research Site
Tsu, 514-8507
Research Site
Yokohama, 236-0004
Research Site
Yokohama, 245-8575
China19 sites
Research Site
Baotou, 014010
Research Site
Beijing, 100057
Research Site
Beijing, 100069
Research Site
Chengdu, 610072
Research Site
Fuzhou, 350005
Research Site
Guangzhou, 510515
Research Site
Hangzhou, 310003
Research Site
Liaocheng, 252000
Research Site
Nanchang, 330000
Research Site
Qingdao, 266011
Research Site
Shanghai, 200025
Research Site
Shanghai, 200080
Research Site
Shanghai, 200092
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Shenyang, 110004
Research Site
Taiyuan, 030001
Research Site
Wenzhou, 325000
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Xi'an, 710061
Research Site
Xuzhou, 221000
Research Site
Zhenjiang, 212021
Argentina7 sites
Research Site
CABA, C1061
Research Site
CABA, C1426
Research Site
Ciudad de Buenos Aires, 1280
Research Site
Córdoba, X5000EPU
Research Site
La Plata, 1900
Research Site
Mar del Plata, B7600GNY
Research Site
San Juan Bautista, 1888
Mexico7 sites
Research Site
Acapulco, 39670
Research Site
Guadalajara, 44340
Research Site
Mexico City, 03330
Research Site
Mexico City, 06700
Research Site
Torreón, 27000
Research Site
Veracruz, 91851
Research Site
Xalapa, 91020
Brazil6 sites
Research Site
Botucatu, 18618-687
Research Site
Porto Alegre, 90035-000
Research Site
Porto Alegre, 90035-903
Research Site
Salvador, 40110-160
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 05403-000
Turkey (Türkiye)6 sites
Research Site
Adana, 01060
Research Site
Antalya, 07059
Research Site
Bursa, 16059
Research Site
Eskişehir, 26480
Research Site
Izmir, 35340
Research Site
Rize, 530020
India5 sites
Research Site
Hyderabad, 500072
Research Site
Jaipur, 302001
Research Site
Jaipur, 302018
Research Site
Punjab, 160062
Research Site
Surat, 395009
Italy5 sites
Research Site
Milan, 20122
Research Site
Palermo, 90127
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Roma, 00128
Research Site
Rome, 00168
Research Site
Torino, 10126
Malaysia5 sites
Research Site
Kota Kinabalu, 88586
Research Site
Kuala Lumpur, 56000
Research Site
Kuala Lumpur, 59100
Research Site
Pulau Pinang, 10450
Research Site
Seremban, 70300
Spain5 sites
Research Site
A Coruña, 15006
Research Site
Almería, 04009
Research Site
Lleida, 25198
Research Site
Málaga, 29010
Research Site
Zaragoza, 50009
Taiwan5 sites
Research Site
Kaohsiung City, 80756
Research Site
Tainan, 70403
Research Site
Taipei, 10002
Research Site
Taipei, 112
Research Site
Taoyuan, 333
Thailand5 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Chile4 sites
Research Site
Santiago, 7620157
Research Site
Santiago, 8380456
Research Site
Santiago
Research Site
Valdivia, 5110683
Germany4 sites
Research Site
Konstanz, 78464
Research Site
Magdeburg
Research Site
Mainz, 55131
Research Site
Münster, 48149
Peru4 sites
Research Site
Chorrillos, Lima 9
Research Site
Lima, 15023
Research Site
Lima, 15036
Research Site
Lima, 15046
Philippines4 sites
Research Site
Cebu, 6000
Research Site
Puerto Princesa City, 5300
Research Site
Roxas City, 5800
Research Site
San Fernando City, 2000
Singapore3 sites
Research Site
Singapore, 119074
Research Site
Singapore, 169608
Research Site
Singapore, 308433
South Korea3 sites
Research Site
Junggu, 41944
Research Site
Seoul, 03080
Research Site
Seoul, 06351
Hong Kong2 sites
Research Site
Hong Kong, 999077
Research Site
Shatin, 999077
Vietnam2 sites
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
About this study
Official title: 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
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- AZD2693, Placebo
- Keywords
- Nonalcoholic Steatohepatitis, NASH, fatty liver disease, Non alcoholic fatty liver, liver fibrosis, PNPLA3 148M Risk Allele, Non Cirrhotic
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2693Drug
AZD2693 solution SC once per month
PlaceboOther
Sodium chloride 0.9% solution SC once per month
| Study group | Role | What they receive |
|---|---|---|
| AZD2693 dose 1 | Experimental | Participants will receive AZD2693 dose 1 Receives: Drug: AZD2693 |
| AZD2693 dose 2 | Experimental | Participants will receive AZD2693 dose 2 Receives: Drug: AZD2693 |
| Placebo | Placebo comparator | Participants in this arm will receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving NASH Resolution Without Worsening of Fibrosis Based on Histology After 52 Weeks of Treatment
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 of treatment
Measured: From baseline to week 54
Secondary outcomes (3)
Proportion of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH Based on Biopsy After 52 Weeks of Treatment
To assess the effects of AZD2693 versus placebo on histological fibrosis improvement
Measured: From baseline to week 54
Proportion of Participants With ≥ 2-point Improvement From Baseline in NAS Based on Biopsy After 52 Weeks of Treatment
To assess the effect of AZD2693 versus placebo on ≥ 2-point improvement in NAS
Measured: From baseline to week 54
Proportion of Participants With Improvement in Fibrosis by at Least One Stage Based on Biopsy After 52 Weeks of Treatment
To assess the effect of AZD2693 versus placebo on improvement in fibrosis by at least one stage
Measured: From baseline to week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start15 Mar 2023
- Primary completion14 Jul 2025
- Study completion29 Sep 2025
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 SteatohepatitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Model description
- Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809934
- Sponsor's protocol ID
- D7830C00004
- Other IDs
- 2023-509704-14-00, 2022-001629-65, 2023
- Acronym
- FORTUNA
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2023
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05809934
- Acronym / sponsor ID
- FORTUNA / D7830C00004
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Nonalcoholic Steatohepatitis, NASH, fatty liver disease, Non alcoholic fatty liver, liver fibrosis, PNPLA3 148M Risk Allele, Non Cirrhotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study
| Arm | Type | Receives |
|---|---|---|
| AZD2693 dose 1 | Experimental | Drug: AZD2693Participants will receive AZD2693 dose 1 |
| AZD2693 dose 2 | Experimental | Drug: AZD2693Participants will receive AZD2693 dose 2 |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will receive placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| AZD2693AZD2693 solution SC once per month | Drug | AZD2693 dose 1, AZD2693 dose 2 |
| PlaceboSodium chloride 0.9% solution SC once per month | Other | Placebo |
Primary outcome
Proportion of Participants Achieving NASH Resolution Without Worsening of Fibrosis Based on Histology After 52 Weeks of Treatment
Time frame: From baseline to week 54
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 of treatment
3 secondary outcomes
Proportion of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH Based on Biopsy After 52 Weeks of Treatment
Time frame: From baseline to week 54
Proportion of Participants With ≥ 2-point Improvement From Baseline in NAS Based on Biopsy After 52 Weeks of Treatment
Time frame: From baseline to week 54
Proportion of Participants With Improvement in Fibrosis by at Least One Stage Based on Biopsy After 52 Weeks of Treatment
Time frame: From baseline to week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SAP RedactedLink provided by the sponsor.
- CSR Synopsis RedactedLink provided by the sponsor.
- CSP RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
163 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2693 in people with Nonalcoholic Steatohepatitis, run by AstraZeneca at 163 sites in 22 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 11 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 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 163 sites in United States, Japan, China, Argentina, Mexico and 17 more countries. 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 2026). 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?
Proportion of Participants Achieving NASH Resolution Without Worsening of Fibrosis Based on Histology After 52 Weeks of Treatment (time frame: From baseline to week 54). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.