GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / NNC0194-0499 / Semaglutide

Listed sites

102

Recruiting sites

—

Enrollment

270

actual

Study population

Alcohol / substance use, MASH / NAFLD / liver fibrosis

Key I/E criterion

—

Primary endpoint

•ELF score, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06409130

Org study IDNN9500-7730

Secondary ID2023-508170-28European Medical Agency (EMA)

Secondary IDU1111-1295-6713World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-05-10actual

Study start2024-05-20actual

Primary completion2025-11-21actual

Study completion2026-01-12actual

Last update posted2026-03-12actual

Assets

Investigational agents

CagriSema / cagrilintide NNC0194-0499 Semaglutide

Study populations

Who this study enrolls

Alcohol / substance useMASH / NAFLD / liver fibrosis

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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 9.0 units.

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 human immunodeficiency virus-1 (HIV-1) or HIV-2 antibody (Ab), 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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Cardiometabolic biomarkers

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

MASH / liver

6 endpoints

Primary/protocol endpoint

Change in Enhanced Liver Fibrosis (ELF)

Time frame:From week 0 to week 28

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Pro-peptide of Collagen 3 (Pro-C3)

Time frame:From week 0 to week 28

ratio, improvement

Secondary/protocol endpoint

Change in liver stiffness assessed by Vibration Controlled Transient Elastography (VCTE)

Time frame:From week 0 to week 28

Liver stiffness (VCTE), change

ratio, improvement

Secondary/protocol endpoint

Change in liver steatosis assessed by Controlled Attenuated Parameter (CAP)

Time frame:From week 0 to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in Alanine Aminotransferase (ALT)

Time frame:From week 0 to week 28

ALT, change

ratio, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change in Aspartate Aminotransferase (AST)

Time frame:From week 0 to week 28

AST, change

ratio, improvement

LOINC 1920-8

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in total cholesterol

Time frame:From week 0 to week 28

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:From week 0 to week 35

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in alcohol amount measured by timeline followback (TLFB)

Time frame:From week -4 to week 28

Alcohol consumption, change

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Phosphatidylethanol (PEth)

Time frame:From week -4 to week 28

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.