Non-cirrhotic Non-alcoholic Steatohepatitis With FibrosisPhase 2PROXYMO-ADVNCT05364931
A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
A Phase 2 study testing Cotadutide in people with Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis, run by AstraZeneca at 115 sites in 20 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
- What is being tested?
- Cotadutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 115 sitesin 20 countries
- Study dates
- 14 Jul 2022to 19 Apr 2024
- 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
- Provision of informed consent
- Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
- Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:
- NAS (Non-alcoholic Fatty Liver Disease Activity Score) ≥ 4 with a score of ≥ 1 for each component: steatosis, lobular inflammation, and ballooning
- Presence of fibrosis stage F2 or F3
- Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
Who cannot join
- Chronic liver disease of other etiologies.
- History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).
- Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening
- History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
- Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.
- Severe allergy/hypersensitivity to any of the proposed study treatments or excipients
- Contraindication to liver biopsy (eg, bleeding diathesis, such as hemophilia, suspected hemangioma, or suspected echinococcal infection) or inability to safely obtain a liver biopsy as determined by the investigator
- Severely uncontrolled hypertension defined as SBP ≥ 180 mmHg or DBP ≥ 110 mmHg on the average of 2 seated BP measurements after being at rest for at least 10 minutes at screening or randomization 9 Any positive results for human immunodeficiency virus infection, positive results for hepatitis B surface antigen or hepatitis C antibody test along with a positive HCV RNA test.
Trial locations and contacts
115 sites in 20 countries.
115 sites in 20 countries
United States29 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Arlington, Texas, 76012
Research Site
Austin, Texas, 78745
Research Site
Bradenton, Florida, 34208
Research Site
Canoga Park, California, 91303
Research Site
Chattanooga, Tennessee, 37421
Research Site
Dallas, Texas, 75230
Research Site
Englewood, Colorado, 80113
Research Site
Gilroy, California, 95020
Research Site
Homestead, Florida, 33032
Research Site
Houma, Louisiana, 70363
Research Site
Jacksonville, Florida, 32216
Research Site
Las Vegas, Nevada, 89104
Research Site
Las Vegas, Nevada, 89109
Research Site
Lawrence, New Jersey, 08648
Research Site
Lewisville, Texas, 75057
Research Site
Marrero, Louisiana, 70006
Research Site
Marrero, Louisiana, 70072
Research Site
Miami, Florida, 33175
Research Site
Miami, Florida, 33176
Research Site
Morehead City, North Carolina, 28557
Research Site
Munster, Indiana, 46321
Research Site
Ogden, Utah, 84403
Research Site
Sacramento, California, 95821
Research Site
San Antonio, Texas, 78215
Research Site
Shreveport, Louisiana, 71105
Research Site
Tucson, Arizona, 85712
Research Site
Warren Township, New Jersey, 07059
Research Site
Winter Park, Florida, 32789
Japan17 sites
Research Site
Chiba, 260-8677
Research Site
Fukui-shi, 918-8503
Research Site
Gifu, 500-8513
Research Site
Hiroshima, 734-8551
Research Site
Kawasaki-shi, 215-0026
Research Site
Kawasaki-shi, 216-8511
Research Site
Kure-shi, 737-0023
Research Site
Osaka, 637086
Research Site
Saga, 849-8501
Research Site
Sapporo, 062-0921
Research Site
Sendai, 980-0873
Research Site
Shinjuku-ku, 160-0023
Research Site
Suita-shi, 564-0013
Research Site
Takasaki-shi, 370-0829
Research Site
Toon-shi, 791-0281
Research Site
Yokohama, 236-0004
Research Site
Yokohama, 245-8575
United Kingdom8 sites
Research Site
Aberdeen, AB25 2ZN
Research Site
Glasgow, G51 4LB
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Ipswich, IP4 5PD
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Liverpool, L1 9ED
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London, EN1 1LJ
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Preston, PR2 9QB
Research Site
Rochdale, OL11 4AU
Research Site
Sheffield, S2 5FX
Italy7 sites
Research Site
Catania, 95100
Research Site
Foggia, 71100
Research Site
Milan, 20127
Research Site
Roma, 00100
Research Site
Roma, 00161
Research Site
Rozzano, 20089
Research Site
San Giovanni Rotondo, 71013
Israel6 sites
Research Site
Haifa, 34362
Research Site
Jerusalem, 91031
Research Site
Nahariya, 22100
Research Site
Petah Tikva, 49100
Research Site
Tel Aviv, 64239
Research Site
Tel HaShomer, 52621
South Korea6 sites
Research Site
Busan, 49241
Research Site
Gangwon-do, 26426
Research Site
Junggu, 41944
Research Site
Seoul, 03080
Research Site
Seoul, 04763
Research Site
Seoul, 06351
Spain6 sites
Research Site
A Coruña, 15006
Research Site
Almería, 04009
Research Site
Lleida, 25198
Research Site
Madrid, 28046
Research Site
Málaga, 29010
Research Site
Seville, 41013
Australia5 sites
Research Site
Heidelberg, 3084
Research Site
Kogarah, 2217
Research Site
Meadowbrook, 4131
Research Site
Melbourne, 3004
Research Site
Westmead, 2145
Taiwan5 sites
Research Site
Kaohsiung City, 80756
Research Site
Tainan, 70403
Research Site
Taipei, 110
Research Site
Taipei, 11217
Research Site
Taipei, 114
Thailand5 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Malaysia4 sites
Research Site
Kuala Lumpur, 56000
Research Site
Kuala Lumpur, 59100
Research Site
Malacca, 75400
Research Site
Seremban, 70300
New Zealand3 sites
Research Site
Auckland, 2025
Research Site
Christchurch, 8011
Research Site
Grafton, 1023
Canada2 sites
Research Site
London, Ontario, N6A 5A5
Research Site
Terrebonne, Quebec, J6X 4P7
Turkey (Türkiye)2 sites
Research Site
Ankara, 06800
Research Site
Istanbul, 34093
About this study
Official title: A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
Read the detailed description
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.
- Being tested
- Cotadutide, Placebo
- Keywords
- NASH, fatty liver disease, non-alcoholic fatty liver, NAS, liver fibrosis, Non-alcoholic steatohepatitis
- 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.
CotadutideDrug
Cotadutide administered subcutaneously once daily
PlaceboDrug
Placebo administered subcutaneously once daily
| Study group | Role | What they receive |
|---|---|---|
| Cotadutide 300μg | Experimental | Not described Receives: Drug: Cotadutide |
| Placebo 300μg | Placebo comparator | Not described Receives: Drug: Placebo |
| Cotadutide 600μg | Experimental | Not described Receives: Drug: Cotadutide |
| Placebo 600μg | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs).
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
Measured: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Vital Signs.
To assess safety and tolerability of Cotadutide.
Measured: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Abnormal Laboratory Assessments
To assess safety and tolerability of Cotadutide.
Measured: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
To assess safety and tolerability of Cotadutide.
Measured: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
To assess the immunogenicity of Cotadutide
Measured: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
Titer of Treatment-induced Anti-Drug Antibody (ADA)
To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.
Measured: From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start14 Jul 2022
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
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 Non-cirrhotic Non-alcoholic Steatohepatitis With FibrosisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364931
- Sponsor's protocol ID
- D5671C00006
- Other IDs
- 2021-005484-53
- Acronym
- PROXYMO-ADV
- Status last verified
- Aug 2025
- First submitted
- 4 May 2022
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
- ClinicalTrials.gov ID
- NCT05364931
- Acronym / sponsor ID
- PROXYMO-ADV / D5671C00006
- Keywords
- NASH, fatty liver disease, non-alcoholic fatty liver, NAS, liver fibrosis, Non-alcoholic steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
Detailed description
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of cotadutide at 300 and 600 μg in participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis.
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 |
|---|---|---|
| Cotadutide 300μg | Experimental | Drug: Cotadutide |
| Placebo 300μg | Placebo comparator | Drug: Placebo |
| Cotadutide 600μg | Experimental | Drug: Cotadutide |
| Placebo 600μg | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of informed consent
- Males and female participants ≥ 18 to ≤ 75 years of age (inclusive) at the time of signing the informed consent.
- Histologically confirmed non-alcoholic steatohepatitis (NASH) per NASH Clinical Research Network (CRN) criteria as diagnosed by histology from a liver biopsy performed ≤ 180 days from randomization and fulfilling all of the following histological criteria:
- Women of childbearing potential, non-pregnant and nonbreastfeeding and using appropriate birth control to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study intervention.
Key exclusion criteria (8 listed)
- Chronic liver disease of other etiologies.
- History of cirrhosis and/or hepatic decompensation, including evidence of portal hypertension (e.g. low platelet count, splenomegaly, ascites, history of hepatic encephalopathy, esophageal varices, or variceal bleeding).
- Clinically significant cardiovascular or cerebrovascular disease within 90 days prior to screening, including but not limited to, myocardial infarction, acute coronary syndrome, unstable angina pectoris, transient ischemic attack, or stroke, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 90 days or who are due to undergo these procedures at the time of screening
- History of malignant neoplasms within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or any in situ carcinoma.
- Participation in another clinical study with an investigational product administered within the last 30 days or 5 half-lives of the therapy (whichever is longer) at the time of screening or the time of the historical biopsy or concurrent participation in another interventional study of any kind or prior randomization in this study.
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 |
|---|---|---|
| CotadutideCotadutide administered subcutaneously once daily | Drug | Cotadutide 300μg, Cotadutide 600μg |
| PlaceboPlacebo administered subcutaneously once daily | Drug | Placebo 300μg, Placebo 600μg |
Primary outcome
Number of Participants With Adverse Events (AEs).
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide. Occurrence of AEs and serious AEs, including AEs leading to dose reduction, and AEs of special interest.
Number of Participants With Abnormal Vital Signs.
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Participants With Abnormal Laboratory Assessments
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Participants With Treatment Emergent Abnormality in 12-lead Electrocardiogram (ECG).
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess safety and tolerability of Cotadutide.
Number of Treatment-induced Anti-Drug Antibody (ADA) Participants
Time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.
To assess the immunogenicity of Cotadutide
Titer of Treatment-induced Anti-Drug Antibody (ADA)
Time frame: From first dose on Day 1 until the follow-up period, 28 days post last dose (from randomization up to approximately 52 weeks).
To assess the immunogenicity of cotadutide. Titers represent a dilution and are therefore unitless. Summary statistics are based on the maximum observed titer for each ADA positive subject within the time frame.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR SynopsisLink 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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NASH With Fibrosis, MASH With Fibrosis
Active, not recruitingPhase 3
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 )
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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.
115 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cotadutide in people with Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis, run by AstraZeneca at 115 sites in 20 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 6 inclusion and 8 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, Japan, United Kingdom, Italy, Israel and 15 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 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs). (time frame: First dose on Day 1 until the follow-up period, 28 days post last dose, up to approximately 52 weeks.). The study lists 6 primary outcomes in all. 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 3 Sep 2025.