GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Fibrosis ≥1-stage improvement, no MASH worsening

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 IDNCT03987451

Org study IDNN9931-4492

Secondary ID2018-004484-31European Medicines Agency (EudraCT)

Secondary IDU1111-1224-4062World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-06-17actual

Study start2019-06-18actual

Primary completion2021-04-22actual

Study completion2021-06-10actual

Last update posted2024-05-29actual

Results first posted2024-05-29actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.

•Histologic evidence of NASH and fibrosis stage 4 according to the NASH CRN classification based on central pathologist evaluation of a liver biopsy obtained within 360 days prior to screening. In subjects who have never had a liver biopsy showing NASH and F4, liver stiffness above 14 kPa by FibroScan® at screening must be documented before subjects can have a trial-related liver biopsy

•A histological NAFLD activity score (NAS) equal to or above 3 with a score of 1 or more in lobular inflammation and hepatocyte ballooning based on central pathologist evaluation

•Body mass index equal to or above 27 kg/m^2

Exclusion criteria

•Presence or history of hepatic decompensation (e.g. ascites, variceal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis) or liver transplantation

•Presence or history of gastroesophageal varices within the past 360 days prior to screening. For subjects with no known history of gastroesophageal varices and with a Fibroscan® equal to or above 20 kPa and thrombocytes equal to or below 150,000, a esophagogastroduodenoscopy must be performed to evaluate presence of gastroesophageal varices

•Presence or history of hepatocellular carcinoma

•Treatment with vitamin E (at doses equal to or above 800 IU/day) or pioglitazone which has not been at a stable dose in the opinion of the investigator in the period from 90 days prior to screening

•Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the period from 90 days prior to screening

•Treatment with other glucose lowering agent(s) (apart from what is listed in the exclusion criterion above) or weight loss medication not stable in the opinion of the investigator in the period from 28 days prior to screening

Endpoints (96)

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

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Renal / kidney

Other (unclassified)

Weight & body composition

12 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline (week 0), Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms	95% CI
Semaglutide 2.4 mg	-8.6	—
Placebo	-0.8	—

Secondary/registry result

Relative Change From Baseline in Body Weight

Time frame:Baseline (week 0), Week 48

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Semaglutide 2.4 mg	-8.83	—
Placebo	-0.09	—

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline (week 0), Week 48

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters	95% CI
Semaglutide 2.4 mg	-6.3	—
Placebo	0.4	—

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (week 0), Week 48

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms per meter square	95% CI
Semaglutide 2.4 mg	-3.1	—
Placebo	-0.2	—

Secondary/registry result

Percentage of Participants With Weight Loss of >= 5% of Baseline Body Weight at Week 48

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mg	62.0	—
Placebo	25.4	—

Secondary/registry result

Percentage of Participants With Weight Loss of >= 10% of Baseline Body Weight at Week 48

Time frame:Week 48

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mg	40.5	—
Placebo	0	—

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline (week 0), Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Relative Change From Baseline in Body Weight

Time frame:Baseline (week 0), Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline (week 0), Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (week 0), Week 48

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Weight Loss of >= 5% of Baseline Body Weight at Week 48

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Weight Loss of >= 10% of Baseline Body Weight at Week 48

Time frame:Week 48

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c)

Time frame:Baseline (week 0), Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1C	95% CI
Semaglutide 2.4 mg	-1.4	—
Placebo	0.2	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), millimoles per liter (mmol/L)	95% CI
Semaglutide 2.4 mg	-2.20	—
Placebo	0.23	—

Secondary/registry result/low confidence

Change From Baseline in Fasting C-peptide-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

C-peptide AUC

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting C-peptide	95% CI
Semaglutide 2.4 mg	0.95	—
Placebo	1.00	—

Secondary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c)

Time frame:Baseline (week 0), Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change From Baseline in Fasting C-peptide-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

C-peptide AUC

ratio, improvement

MASH / liver

52 endpoints

Primary/registry result

Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks

Time frame:Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mg	10.6	—
Placebo	29.2	—

Odds Ratio (OR)0.2895% CI0.06 – 1.24p0.0867Cochran-Mantel-Haenszel

The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.

Primary/protocol endpoint

Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks

Time frame:Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

SNOMED 442685003

Secondary/registry result

Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Liver fat content, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of liver fat content	95% CI
Semaglutide 2.4 mg	0.62	—
Placebo	1.01	—

Secondary/registry result

Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Liver stiffness (VCTE), change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of liver stiffness	95% CI
Semaglutide 2.4 mg	0.87	—
Placebo	0.98	—

Secondary/registry result

Percentage of Participants With NASH Resolution After 48 Weeks

Time frame:Week 48

MASH resolution, no fibrosis worsening

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mg	34.0	—
Placebo	20.8	—

Secondary/registry result

Change From Baseline in Fibrosis-4 Score-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fibrosis-4 score	95% CI
Semaglutide 2.4 mg	0.9	—
Placebo	1.0	—

Secondary/registry result

Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	61.7	—
Worsening	2.1	—
No change	21.3	—
Missing	14.9	—
PlaceboImprovement	58.3	—
Worsening	16.7	—
No change	20.8	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	12.8	—
Worsening	0.0	—
No change	72.3	—
Missing	14.9	—
PlaceboImprovement	33.3	—
Worsening	0.0	—
No change	62.5	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in Hepatocyte Ballooning

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	55.3	—
Worsening	2.1	—
No change	27.7	—
Missing	14.9	—
PlaceboImprovement	33.3	—
Worsening	8.3	—
No change	54.2	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in Lobular Inflammation

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	42.6	—
Worsening	12.8	—
No change	29.8	—
Missing	14.9	—
PlaceboImprovement	37.5	—
Worsening	12.5	—
No change	45.8	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in Steatosis

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	44.7	—
Worsening	2.1	—
No change	38.3	—
Missing	14.9	—
PlaceboImprovement	33.3	—
Worsening	16.7	—
No change	45.8	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in The Steatosis-Activity-Fibrosis (SAF) Activity Component Score

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	57.4	—
Worsening	8.5	—
No change	19.1	—
Missing	14.9	—
PlaceboImprovement	50.0	—
Worsening	12.5	—
No change	33.3	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Change in The Ishak Fibrosis Score

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgImprovement	27.7	—
Worsening	2.1	—
No change	55.3	—
Missing	14.9	—
PlaceboImprovement	37.5	—
Worsening	12.5	—
No change	45.8	—
Missing	4.2	—

Secondary/registry result

Change From Baseline in Hepatic Collagen

Time frame:Baseline (week 0), Week 48

change from baseline, improvement

Posted result

Group	Value (mean), Percentage of hepatic collagen	95% CI
Semaglutide 2.4 mg	-1.7	—
Placebo	-1.2	—

Secondary/registry result

Percentage of Participants With Improvement in Fibrosis Stage According to The Kleiner Fibrosis Classification (Yes/No)

Time frame:Baseline (week 0), Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	12.8	—
No	72.3	—
Missing	14.9	—
PlaceboYes	33.3	—
No	62.5	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in Hepatocyte Ballooning (Yes/No)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	55.3	—
No	29.8	—
Missing	14.9	—
PlaceboYes	33.3	—
No	62.5	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in Lobular Inflammation (Yes/No)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	42.6	—
No	42.6	—
Missing	14.9	—
PlaceboYes	37.5	—
No	58.3	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in Steatosis (Yes/No)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	44.7	—
No	40.4	—
Missing	14.9	—
PlaceboYes	33.3	—
No	62.5	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in NAS (Yes/No)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	61.7	—
No	23.4	—
Missing	14.9	—
PlaceboYes	58.3	—
No	37.5	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in SAF Activity Component Score (Yes/No)

Time frame:Baseline (week 0), Week 48

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	57.4	—
No	27.7	—
Missing	14.9	—
PlaceboYes	50.0	—
No	45.8	—
Missing	4.2	—

Secondary/registry result

Percentage of Participants With Improvement in Ishak Fibrosis Score (Yes/No)

Time frame:Baseline (week 0), Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Semaglutide 2.4 mgYes	27.7	—
No	57.4	—
Missing	14.9	—
PlaceboYes	37.5	—
No	58.3	—
Missing	4.2	—

Secondary/registry result

Change From Baseline in Alanine Aminotransferase (ALT)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ALT, change

ratio, improvement

LOINC 1742-6

Posted result

Group	Value (geometric_mean), Ratio of ALT	95% CI
Semaglutide 2.4 mg	0.7	—
Placebo	1.0	—

Secondary/registry result

Change From Baseline in Aspartate Aminotransferase (AST)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

AST, change

ratio, improvement

LOINC 1920-8

Posted result

Group	Value (geometric_mean), Ratio of AST	95% CI
Semaglutide 2.4 mg	0.7	—
Placebo	1.0	—

Secondary/registry result

Change From Baseline in Gamma-Glutamyl Transferase (GGT)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

γ-GT, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of GGT	95% CI
Semaglutide 2.4 mg	0.7	—
Placebo	1.0	—

Secondary/registry result

Change From Baseline in International Normalized Ratio (INR)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of INR	95% CI
Semaglutide 2.4 mg	1.02	—
Placebo	1.01	—

Secondary/registry result

Change From Baseline in Direct Bilirubin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of direct bilirubin	95% CI
Semaglutide 2.4 mg	1.1	—
Placebo	1.0	—

Secondary/registry result

Change From Baseline in Total Bilirubin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of total bilirubin	95% CI
Semaglutide 2.4 mg	1.0	—
Placebo	0.9	—

Secondary/protocol endpoint

Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Liver fat content, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Liver stiffness (VCTE), change

ratio, improvement

Secondary/protocol endpoint

Percentage of Participants With NASH Resolution After 48 Weeks

Time frame:Week 48

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Secondary/protocol endpoint

Change From Baseline in Fibrosis-4 Score-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in Hepatocyte Ballooning

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in Lobular Inflammation

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in Steatosis

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in The Steatosis-Activity-Fibrosis (SAF) Activity Component Score

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Change in The Ishak Fibrosis Score

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Change From Baseline in Hepatic Collagen

Time frame:Baseline (week 0), Week 48

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in Fibrosis Stage According to The Kleiner Fibrosis Classification (Yes/No)

Time frame:Baseline (week 0), Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in Hepatocyte Ballooning (Yes/No)

Time frame:Baseline (week 0), Week 48

categorical status, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in Lobular Inflammation (Yes/No)

Time frame:Baseline (week 0), Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in Steatosis (Yes/No)

Time frame:Baseline (week 0), Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in NAS (Yes/No)

Time frame:Baseline (week 0), Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in SAF Activity Component Score (Yes/No)

Time frame:Baseline (week 0), Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Improvement in Ishak Fibrosis Score (Yes/No)

Time frame:Baseline (week 0), Week 48

Fibrosis ≥1-stage improvement, no MASH worsening

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Alanine Aminotransferase (ALT)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ALT, change

ratio, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change From Baseline in Aspartate Aminotransferase (AST)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

AST, change

ratio, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change From Baseline in Gamma-Glutamyl Transferase (GGT)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

γ-GT, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in International Normalized Ratio (INR)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Direct Bilirubin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Total Bilirubin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Renal / kidney

2 endpoints

Secondary/registry result/low confidence

Change From Baseline in Albumin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of albumin	95% CI
Semaglutide 2.4 mg	1.0	—
Placebo	1.0	—

Secondary/protocol endpoint/low confidence

Change From Baseline in Albumin-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, improvement

Cardiometabolic biomarkers

18 endpoints

Secondary/registry result

Change From Baseline in Systolic And Diastolic Blood Pressure

Time frame:Baseline (week 0), Week 48

change from baseline, improvement

Posted result

Group	Value (mean), millimeter of mercury	95% CI
Semaglutide 2.4 mgChange From Baseline in Systolic Blood Pressure	-4.1	—
Change From Baseline in Diastolic Blood Pressure	0.4	—
PlaceboChange From Baseline in Systolic Blood Pressure	0.1	—
Change From Baseline in Diastolic Blood Pressure	-0.7	—

Secondary/registry result

Change From Baseline in Total Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 2.4 mg	0.98	—
Placebo	1.05	—

Secondary/registry result

Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide 2.4 mg	0.99	—
Placebo	1.02	—

Secondary/registry result

Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide 2.4 mg	1.07	—
Placebo	0.99	—

Secondary/registry result

Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Semaglutide 2.4 mg	0.90	—
Placebo	1.09	—

Secondary/registry result

Change From Baseline in Triglycerides-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.90	—
Placebo	1.09	—

Secondary/registry result

Change From Baseline in Free Fatty Acids (FFA)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of FFA	95% CI
Semaglutide 2.4 mg	1.07	—
Placebo	1.43	—

Secondary/registry result

Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of hsCRP	95% CI
Semaglutide 2.4 mg	0.63	—
Placebo	1.13	—

Secondary/registry result

Change From Baseline in Pulse

Time frame:Baseline (week 0), Week 48

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute	95% CI
Semaglutide 2.4 mg	6	—
Placebo	2	—

Secondary/protocol endpoint

Change From Baseline in Systolic And Diastolic Blood Pressure

Time frame:Baseline (week 0), Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Triglycerides-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Free Fatty Acids (FFA)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change From Baseline in Pulse

Time frame:Baseline (week 0), Week 48

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment-Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 55

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	290	—
Placebo	85	—

Secondary/registry result

Number of Treatment-Emergent Hypoglycaemic Episodes

Time frame:From baseline (week 0) to week 55

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 2.4 mg	34	—
Placebo	15	—

Secondary/protocol endpoint

Number of Treatment-Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to week 55

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-Emergent Hypoglycaemic Episodes

Time frame:From baseline (week 0) to week 55

Documented hypoglycemia

event count, event

Other (unclassified)

2 endpoints

Secondary/registry result/low confidence

Changes From Baseline in Thrombocytes-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of thrombocytes	95% CI
Semaglutide 2.4 mg	1.0	—
Placebo	1.0	—

Secondary/protocol endpoint/low confidence

Changes From Baseline in Thrombocytes-Ratio to Baseline

Time frame:Baseline (week 0), Week 48

ratio, descriptive

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Similar weight loss with semaglutide regardless of diabetes and cardiometabolic risk parameters in individuals with metabolic dysfunction-associated steatotic liver disease: Post hoc analysis of three randomised controlled trials.
Diabetes, obesity & metabolism2025 Feb (month)PMID39609879doi:10.1111/dom.16065via pubmed nct search
Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial.
The lancet. Gastroenterology & hepatology2023 Jun (month)PMID36934740doi:10.1016/S2468-1253(23)00068-7via CT.gov background + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.