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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06409130




Registration number
NCT06409130
Ethics application status
Date submitted
7/05/2024
Date registered
10/05/2024

Titles & IDs
Public title
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
Scientific title
Effects of NNC0194-0499 Alone and in Combination With Semaglutide, of Semaglutide Alone, and of Cagrilintide Alone and in Combination With Semaglutide on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
Secondary ID [1] 0 0
U1111-1295-6713
Secondary ID [2] 0 0
NN9500-7730
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related Liver Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNC0194-0499
Treatment: Drugs - Semaglutide
Treatment: Drugs - NNC0194-0499 placebo
Treatment: Drugs - Semaglutide placebo (Group A)
Treatment: Drugs - Cagrilintide + semaglutide
Treatment: Drugs - Cagrilintide
Treatment: Drugs - Cagrilintide placebo
Treatment: Drugs - Semaglutide placebo (Group B)

Experimental: NNC0194-0499 + semaglutide - Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide.

Experimental: NNC0194-0499 + semaglutide placebo - Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 in combination with semaglutide placebo.

Experimental: NNC0194-0499 placebo + semaglutide - Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide.

Placebo comparator: NNC0194-0499 placebo + semaglutide placebo - Group A: Participants will receive subcutaneous (s.c.) injections of NNC0194-0499 placebo in combination with semaglutide placebo.

Experimental: CagriSema - Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide.

Experimental: Cagrilintide + semaglutide placebo - Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide in combination with semaglutide placebo.

Placebo comparator: Cagrilintide placebo + semaglutide placebo - Group B: Participants will receive subcutaneous (s.c.) injection of cagrilintide placebo in combination with semaglutide placebo.


Treatment: Drugs: NNC0194-0499
Administered subcutaneously.

Treatment: Drugs: Semaglutide
Administered subcutaneously.

Treatment: Drugs: NNC0194-0499 placebo
Administered subcutaneously.

Treatment: Drugs: Semaglutide placebo (Group A)
Administered subcutaneously.

Treatment: Drugs: Cagrilintide + semaglutide
Administered subcutaneously.

Treatment: Drugs: Cagrilintide
Administered subcutaneously.

Treatment: Drugs: Cagrilintide placebo
Administered subcutaneously.

Treatment: Drugs: Semaglutide placebo (Group B)
Administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Enhanced Liver Fibrosis (ELF)
Timepoint [1] 0 0
From week 0 to week 28
Secondary outcome [1] 0 0
Change in Pro-peptide of Collagen 3 (Pro-C3)
Timepoint [1] 0 0
From week 0 to week 28
Secondary outcome [2] 0 0
Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)
Timepoint [2] 0 0
From week 0 to week 28
Secondary outcome [3] 0 0
Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)
Timepoint [3] 0 0
From week 0 to week 28
Secondary outcome [4] 0 0
Change in Alanine Aminotransferase (ALT)
Timepoint [4] 0 0
From week 0 to week 28
Secondary outcome [5] 0 0
Change in Aspartate Aminotransferase (AST)
Timepoint [5] 0 0
From week 0 to week 28
Secondary outcome [6] 0 0
Number of treatment emergent adverse events
Timepoint [6] 0 0
From week 0 to week 35
Secondary outcome [7] 0 0
Change in Phosphatidylethanol (PEth)
Timepoint [7] 0 0
From week -4 to week 28
Secondary outcome [8] 0 0
Change in alcohol amount measured by timeline followback (TLFB)
Timepoint [8] 0 0
From week -4 to week 28
Secondary outcome [9] 0 0
Change in total cholesterol
Timepoint [9] 0 0
From week 0 to week 28

Eligibility
Key inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Age 18 years or above, and at the legal drinking age according to local requirements at the time of signing the informed consent.
* Patient-reported history of alcohol overuse for greater than or equal to 5 years with an alcohol history of a mean of greater than or equal to 50 grams (male)/40 grams (female) pr day for the last year leading up to the time of signing informed consent.
* Enhanced Liver Fibrosis (ELF) greater than or equal to 9.8 units.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products (incl. excipients).
* Previous participation (i.e., signed informed consent) in this study. If exclusion criteria 7 is met (Vibration Controlled Transient Elastography liver stiffness measurement (LSM) is greater than or equal to 25 Kilopascal (kPa)), a single rescreening is possible at the investigator's discretion.
* Documented causes of chronic liver disease other than Alcohol-related liver disease (ALD).
* Positive hepatitis B surface antigen (HBsAg), positive anti-human immunodeficiency virus (anti-HIV), positive hepatitis C virus (HCV) ribonucleic acid (RNA) at screening (V1) or any known presence of HCV RNA or HBsAg within 2 years of screening visit 1(V1).
* Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at screening (V1).
* Alcohol hepatitis at randomisation (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA)).
* Vibration Controlled Transient Elastography liver stiffness measurement (LSM) greater than or equal to 25 kPa at visit 2 (V2). If participants meet this criterion, rescreening is allowed once.
* Presence or history of gastro-oesophageal varices greater than or equal to grade 2* at V2. For participants with LSM greater than or equal to 20 kPa as well as blood platelets count less than 150,000 per microliter (µL) of blood an oesophagogastroduodenoscopy performed no more than 52 weeks prior to V2 must be available at V2. *Grade 2: varices projecting by one-third of the luminal diameter that cannot be compressed with air insufflation4.
* Body mass index (BMI) less than or equal to 25 Kilogram Per Square Meter (kg/m^2).
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method with low user-dependency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/09/2025
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Clinical Research - Darlinghurst
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Eastern Clinical Research Unit Box Hill - Box Hill
Recruitment hospital [6] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [7] 0 0
Austin Health - Heidelberg
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Hepatology - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Gorna Oryahovitsa
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Czechia
State/province [19] 0 0
Liberec
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague 2
Country [21] 0 0
Denmark
State/province [21] 0 0
Aalborg
Country [22] 0 0
Denmark
State/province [22] 0 0
Herlev
Country [23] 0 0
Denmark
State/province [23] 0 0
Hvidovre
Country [24] 0 0
Denmark
State/province [24] 0 0
Odense C
Country [25] 0 0
France
State/province [25] 0 0
Angers
Country [26] 0 0
France
State/province [26] 0 0
Lille
Country [27] 0 0
France
State/province [27] 0 0
Venissieux
Country [28] 0 0
Germany
State/province [28] 0 0
Homburg
Country [29] 0 0
Germany
State/province [29] 0 0
Leipzig
Country [30] 0 0
Germany
State/province [30] 0 0
Lübeck
Country [31] 0 0
Germany
State/province [31] 0 0
Mainz
Country [32] 0 0
Germany
State/province [32] 0 0
Münster
Country [33] 0 0
Germany
State/province [33] 0 0
Würzburg
Country [34] 0 0
Greece
State/province [34] 0 0
Attica
Country [35] 0 0
Greece
State/province [35] 0 0
Goudi/Athens
Country [36] 0 0
Greece
State/province [36] 0 0
Thessaloniki
Country [37] 0 0
Italy
State/province [37] 0 0
Firenze
Country [38] 0 0
Italy
State/province [38] 0 0
Genova
Country [39] 0 0
Italy
State/province [39] 0 0
Naples
Country [40] 0 0
Italy
State/province [40] 0 0
Padova
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Japan
State/province [42] 0 0
Bunkyo-ku, Tokyo
Country [43] 0 0
Japan
State/province [43] 0 0
Gifu
Country [44] 0 0
Japan
State/province [44] 0 0
Kanazawa-shi, Ishikawa
Country [45] 0 0
Japan
State/province [45] 0 0
Kumamoto-shi, Kumamoto
Country [46] 0 0
Japan
State/province [46] 0 0
Minato-ku, Tokyo
Country [47] 0 0
Japan
State/province [47] 0 0
Nakagamigun, Okinawa
Country [48] 0 0
Japan
State/province [48] 0 0
Oita-shi, Oita
Country [49] 0 0
Japan
State/province [49] 0 0
Sapporo-shi, Hokkaido
Country [50] 0 0
Japan
State/province [50] 0 0
Suita-shi, Osaka
Country [51] 0 0
Japan
State/province [51] 0 0
Tokyo
Country [52] 0 0
Netherlands
State/province [52] 0 0
Dordrecht
Country [53] 0 0
Netherlands
State/province [53] 0 0
Rotterdam
Country [54] 0 0
Netherlands
State/province [54] 0 0
Tilburg
Country [55] 0 0
Netherlands
State/province [55] 0 0
Utrecht
Country [56] 0 0
Poland
State/province [56] 0 0
Kujawsko-Pomorskie
Country [57] 0 0
Poland
State/province [57] 0 0
Kujawsko-pomorskie
Country [58] 0 0
Poland
State/province [58] 0 0
Malopolskie
Country [59] 0 0
Poland
State/province [59] 0 0
Mazowieckie
Country [60] 0 0
Poland
State/province [60] 0 0
Podlaskie
Country [61] 0 0
Poland
State/province [61] 0 0
Zachodniopomorskie
Country [62] 0 0
Poland
State/province [62] 0 0
Kraków
Country [63] 0 0
Spain
State/province [63] 0 0
Cantabria
Country [64] 0 0
Spain
State/province [64] 0 0
Cataluña
Country [65] 0 0
Spain
State/province [65] 0 0
España
Country [66] 0 0
Spain
State/province [66] 0 0
Galicia
Country [67] 0 0
Spain
State/province [67] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://novonordisk-trials.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06409130