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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05016882




Registration number
NCT05016882
Ethics application status
Date submitted
18/08/2021
Date registered
23/08/2021
Date last updated
6/11/2024

Titles & IDs
Public title
Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH)
Scientific title
Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial
Secondary ID [1] 0 0
U1111-1255-5551
Secondary ID [2] 0 0
NN9500-4656
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic Steatohepatitis 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
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNC0194 0499 50 mg/mL
Treatment: Drugs - Placebo (NNC0194-0499)
Treatment: Drugs - Semaglutide 3 mg/mL
Treatment: Drugs - Semaglutide placebo
Treatment: Drugs - NNC0174 0833 10 mg/mL
Treatment: Drugs - NNC0174 0833 placebo

Experimental: NNC0194-0499 7.5 mg + semaglutide 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Placebo comparator: Placebo (NNC0194-0499) 7.5 mg + semaglutide placebo 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Experimental: NNC0194-0499 15 mg + semaglutide 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Placebo comparator: Placebo (NNC0194-0499) 15 mg + semaglutide placebo 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Experimental: NNC0194-0499 30 mg + semaglutide 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Experimental: NNC0194-0499 30 mg + semaglutide placebo 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Active comparator: Placebo (NNC0194-0499) 30 mg + semaglutide 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Placebo comparator: Placebo (NNC0194-0499) 30 mg + semaglutide placebo 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Experimental: NNC0174-0833 2.4 mg + semaglutide 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.

Placebo comparator: Placebo (NNC0174-0833) 2.4 mg + semaglutide placebo 2.4 mg - Each subject will receive two subcutaneous injections once weekly, consisting of two active drugs or one active drug and one placebo or two placebo injections.


Treatment: Drugs: NNC0194 0499 50 mg/mL
Patients will receive subcutaneous (s.c., under the skin) injections of NNC0194-0499 once weekly The study will last for about 19 months

Treatment: Drugs: Placebo (NNC0194-0499)
Patients will receive subcutaneous (s.c., under the skin) injections of placebo once weekly The study will last for about 19 months

Treatment: Drugs: Semaglutide 3 mg/mL
Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly The study will last for about 19 months

Treatment: Drugs: Semaglutide placebo
Patients will receive subcutaneous (s.c., under the skin) injections of semaglutide placebo once weekly The study will last for about 19 months

Treatment: Drugs: NNC0174 0833 10 mg/mL
Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 once weekly The study will last for about 19 months

Treatment: Drugs: NNC0174 0833 placebo
Patients will receive subcutaneous (s.c., under the skin) injections of NNC0174-0833 placebo once weekly The study will last for about 19 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in liver fibrosis and no worsening of NASH (Yes/No)
Timepoint [1] 0 0
From baseline (week 0) to week 52
Secondary outcome [1] 0 0
Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
Timepoint [1] 0 0
From baseline (week 0) to week 52
Secondary outcome [2] 0 0
Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No)
Timepoint [2] 0 0
From baseline (week 0) to week 52
Secondary outcome [3] 0 0
Change in histology-assessed liver collagen proportionate area
Timepoint [3] 0 0
From baseline (week 0) to week 52
Secondary outcome [4] 0 0
Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)
Timepoint [4] 0 0
From baseline (week 0) to week 52
Secondary outcome [5] 0 0
Improvement in liver fibrosis (Yes/No)
Timepoint [5] 0 0
From baseline (week 0) to week 52
Secondary outcome [6] 0 0
Progression of liver fibrosis (Yes/No)
Timepoint [6] 0 0
From baseline (week 0) to week 52
Secondary outcome [7] 0 0
Worsening in steatohepatitis (Yes/No)
Timepoint [7] 0 0
From baseline (week 0) to week 52
Secondary outcome [8] 0 0
Improvement in ballooning (Yes/No)
Timepoint [8] 0 0
From baseline (week 0) to week 52
Secondary outcome [9] 0 0
Improvement in inflammation (Yes/No)
Timepoint [9] 0 0
From baseline (week 0) to week 52
Secondary outcome [10] 0 0
Improvement in steatosis (Yes/No)
Timepoint [10] 0 0
From baseline (week 0) to week 52
Secondary outcome [11] 0 0
Change in ALT (alanine aminotransferase)
Timepoint [11] 0 0
From baseline (week 0) to week 52
Secondary outcome [12] 0 0
Change in AST (aspartate aminotransferase)
Timepoint [12] 0 0
From baseline (week 0) to week 52
Secondary outcome [13] 0 0
Change in inflammation assessed by HsCRP (high sensitivity C-reactive protein)
Timepoint [13] 0 0
From baseline (week 0) to week 52
Secondary outcome [14] 0 0
Change in ELF (Enhanced Liver Fibrosis) score
Timepoint [14] 0 0
From baseline (week 0) to week 52
Secondary outcome [15] 0 0
Change in HbA1c. For subjects with type 2 diabetes
Timepoint [15] 0 0
From baseline (week 0) to week 52
Secondary outcome [16] 0 0
Change in triglycerides
Timepoint [16] 0 0
From baseline (week 0) to week 52
Secondary outcome [17] 0 0
Change in free fatty acids
Timepoint [17] 0 0
From baseline (week 0) to week 52
Secondary outcome [18] 0 0
Change in LDL (low density lipoprotein) cholesterol
Timepoint [18] 0 0
From baseline (week 0) to week 52
Secondary outcome [19] 0 0
Change in HDL (high density lipoprotein) cholesterol
Timepoint [19] 0 0
From baseline (week 0) to week 52
Secondary outcome [20] 0 0
Relative change in body weight
Timepoint [20] 0 0
From baseline (week 0) to week 52
Secondary outcome [21] 0 0
Change in SF-36 (36-item Short Form Survey) bodily pain
Timepoint [21] 0 0
From baseline (week 0) to week 52
Secondary outcome [22] 0 0
Change in NASH-CHECK (patient-reported outcome measure for non-alcoholic steatohepatitis)pain
Timepoint [22] 0 0
From baseline (week 0) to week 52
Secondary outcome [23] 0 0
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue score
Timepoint [23] 0 0
From baseline (week 0) to week 52
Secondary outcome [24] 0 0
Number of treatment emergent adverse events (TEAEs)
Timepoint [24] 0 0
From baseline (week 0) to week 59

Eligibility
Key inclusion criteria
* Aged greater than or equal to 18 years at the time of signing informed consent. In Republic of Korea, subjects must be aged greater than or equal to 19 years. In Japan, subjects must be aged greater than or equal to 20 years. In Singapore, subjects must be aged greater than or equal to 21 years.
* Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to Visit 1.
* Histological evidence of fibrosis stage 2, 3 or 4 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
* Histological non-alcoholic fatty liver disease (NAFLD) activity score (NAS) greater than or equal to 4 for subjects with F2/F3 or greater than or equal to 3 for subjects with F4 based on a central pathologist evaluation of the baseline liver biopsy. All subjects must have a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Documented causes of chronic liver disease other than NAFLD.
* Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
* Presence or history of ascites more than grade 1, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at V2A.
* For subjects with F4, presence or history of gastro-oesophageal varices more than or equal to grade 2 at V3. An oesophagogastroduodenoscopy performed no more than 52 weeks prior to V3 must be available at V3.
* Known or suspected excessive consumption of alcohol (more than 20 g/day for women or more than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
* Treatment with vitamin E (at doses more than or equal to 800 IU/day) or pioglitazone or medications approved for the treatment of NASH which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.
* Treatment with GLP-1 RAs within 90 days prior to V2A. Subjects with a historical liver biopsy taken more than 90 days prior to V2A are excluded if they receive treatment with GLP-1 RAs from time of biopsy until V2A.
* Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to V2A. In addition, for subjects with a historical liver biopsy taken more than 90 days prior to V2A, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until V2A.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/03/2025
Actual
Sample size
Target
672
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Hepatology- 5E291 - Adelaide
Recruitment hospital [6] 0 0
Monash Health Department of Gastroenterology - Clayton
Recruitment hospital [7] 0 0
St Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
The Alfred Centre - Gastroenterology - Melbourne
Recruitment hospital [10] 0 0
Fiona Stanley Hospital - Hepatology - Murdoch
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Goudi, Athens
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Pisa
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Roma
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Rome
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Chiba-shi, Chiba
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Fukui-shi, Fukui
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Hamamatsu-shi, Shizuoka
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Hatsukaichi-shi, Hiroshima
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Kamigyo-ku, Kyoto
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Kawasaki-shi, Kanagawa
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Kumamoto-shi, Kumamoto
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Minato-ku, Tokyo
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Okayama-shi, Okayama
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Saga-shi, Saga
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Sendai-shi, Miyagi
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Suita-shi, Osaka
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Toon-shi, Ehime
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Wakayama-shi, Wakayama
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Yokohama-shi, Kanagawa
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Seoul
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Malaysia
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Kelantan
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Malaysia
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Wilayah Persekutuan Kuala Lumpur
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Malaysia
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Batu Caves
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Poland
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Malopolskie
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Katowice
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Wroclaw
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Portugal
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Matosinhos
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Portugal
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Lisboa
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Puerto Rico
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San Juan
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Russian Federation
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Penza
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Singapore
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Valladolid
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Kaohsiung
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Taipei
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Kocaeli
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United Kingdom
State/province [114] 0 0
Exeter

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).

NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.

The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.

Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.

The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.

Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.

Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Trial website
https://clinicaltrials.gov/study/NCT05016882
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 1452)
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05016882