| Primary | Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks | NASH resolution defined by NASH clinical research network (CRN) as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, higher scores indicating more severe hepatocellular ballooning/lobular inflammation. Worsening of NASH defined by NASH CRN as increase of at least 1 stage of either lobular inflammation, hepatocyte ballooning or steatosis. Worsening of fibrosis defined by increase in fibrosis at least 1 stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | Full analysis set (FAS) included all randomised participants. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Cochran-Mantel-Haenszel | | 0.0867 | | Odds Ratio (OR) | 0.28 | | | 2-Sided | 95 | 0.06 | 1.24 | | | | | Superiority | | |
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| Secondary | Change From Baseline in Liver Fat Content Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)-Ratio to Baseline | Change in liver fat content (measured as percentage) from baseline to week 48 is presented as ratio to baseline. Liver fat content was assessed via MRI-PDFF technique and results were measured in percentage. MRI-PDFF utilized a gradient echo sequence with low flip angle to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of liver fat content | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). |
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| Secondary | Change From Baseline in Liver Stiffness Measured by Magnetic Resonance Elastography (MRE)-Ratio to Baseline | Change in Liver Stiffness from baseline to week 48 is presented as ratio to baseline. Liver stiffness was measured in kilopascal using MRE. MRE is a technology that uses MRI imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of the liver. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of liver stiffness | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With NASH Resolution After 48 Weeks | NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | |
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| Secondary | Change From Baseline in Fibrosis-4 Score-Ratio to Baseline | Change in fibrosis-4 score from baseline to week 48 is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and age that was calculated using formula: Fibrosis-4 = (Age [years] x AST [units per liter (U/L)]) / (platelets [10^9 cells/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fibrosis-4 score | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). |
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| Secondary | Percentage of Participants With Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 48 or missing data is presented. Worsening was defined as an increase of at least 1 in the NAS; Improvement was defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS and missing refers to participants with missing outcomes for NAS from baseline to week 48. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 |
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| Secondary | Percentage of Participants With Change in The Fibrosis Stage According to The Kleiner Fibrosis Classification | Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 48 or missing data is presented. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Change in Hepatocyte Ballooning | Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 48 or missing data is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Change in Lobular Inflammation | Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 48 or missing data is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Change in Steatosis | Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 48 or missing data is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Change in The Steatosis-Activity-Fibrosis (SAF) Activity Component Score | Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 48 or missing data is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Change in The Ishak Fibrosis Score | Percentage of participants who had improved, worsened, or had no change in the Ishak fibrosis score from baseline to week 48 or missing data is presented. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Hepatic Collagen | Change in hepatic collagen from baseline to week 48 was analysed. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | Percentage of hepatic collagen | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Improvement in Fibrosis Stage According to The Kleiner Fibrosis Classification (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in Kleiner fibrosis classification. The degree of fibrosis was described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in Kleiner fibrosis classification; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). |
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| Secondary | Percentage of Participants With Improvement in Hepatocyte Ballooning (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in hepatocyte ballooning clinical research network (CRN) score. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in hepatocyte ballooning; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | |
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| Secondary | Percentage of Participants With Improvement in Lobular Inflammation (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in lobular inflammation CRN score. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in lobular inflammation; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | |
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| Secondary | Percentage of Participants With Improvement in Steatosis (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in steatosis CRN score. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in steatosis; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Improvement in NAS (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in NAS. NAS was calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in NAS; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo |
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| Secondary | Percentage of Participants With Improvement in SAF Activity Component Score (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in SAF score. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in SAF score; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Improvement in Ishak Fibrosis Score (Yes/No) | Improvement is defined as at least one stage decrease from baseline to week 48 in Ishak fibrosis score. Ishak fibrosis score was assessed on a scale of 0-6, with higher scores indicating more severe disease. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. In below table, 'Yes' infers percentage of participants who achieved at least one stage decrease from baseline to week 48 in Ishak fibrosis score; 'No' infers vice-versa; 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal). | Posted | | Number | | Percentage of participants | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | |
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| Secondary | Change From Baseline in Body Weight | Change in body weight from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | Kilograms | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Relative Change From Baseline in Body Weight | Relative change in body weight (measured as kg) from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Mean | Standard Deviation | percent change | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Waist Circumference | Change in waist circumference from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | centimeters | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Body Mass Index (BMI) | Change in BMI from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | Kilograms per meter square | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Weight Loss of >= 5% of Baseline Body Weight at Week 48 | Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Percentage of Participants With Weight Loss of >= 10% of Baseline Body Weight at Week 48 | Percentage of participants with weight loss of ≥ 10% of baseline body weight at 48 weeks is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. | Posted | | Number | | Percentage of participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) | Change in HbA1c from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis | Posted | | Mean | Standard Deviation | Percentage of HbA1C | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change in FPG from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis | Posted | | Mean | Standard Deviation | millimoles per liter (mmol/L) | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Fasting C-peptide-Ratio to Baseline | Change in fasting C-peptide [measured as nanomoles per litre (nmol/L)] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting C-peptide | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Systolic And Diastolic Blood Pressure | Change in systolic and diastolic blood pressure from baseline to week 48 is presented. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | millimeter of mercury | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Total Cholesterol-Ratio to Baseline | Change in total cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol-Ratio to Baseline | Change in LDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol-Ratio to Baseline | Change in HDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol-Ratio to Baseline | Change in VLDL cholesterol (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of VLDL cholesterol | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Triglycerides-Ratio to Baseline | Change in triglycerides (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Free Fatty Acids (FFA)-Ratio to Baseline | Change in free fatty acids (measured as mmol/L) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of FFA | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in High-Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline | Change in hsCRP (measured as milligrams per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of hsCRP | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Alanine Aminotransferase (ALT)-Ratio to Baseline | Change in ALT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of ALT | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Aspartate Aminotransferase (AST)-Ratio to Baseline | Change in AST (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of AST | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Gamma-Glutamyl Transferase (GGT)-Ratio to Baseline | Change in GGT (measured as units per liter) from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of GGT | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Albumin-Ratio to Baseline | Change in albumin [measured as grams per deciliter (g/dL)] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of albumin | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Changes From Baseline in Thrombocytes-Ratio to Baseline | Change in thrombocytes [measured as 10^9 cells per liter] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of thrombocytes | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in International Normalized Ratio (INR)-Ratio to Baseline | Change in INR from baseline to week 48 is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of INR | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 |
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| Secondary | Change From Baseline in Direct Bilirubin-Ratio to Baseline | Change in direct bilirubin [measured as micromoles per liter (umol/L)] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of direct bilirubin | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Total Bilirubin-Ratio to Baseline | Change in total bilirubin [measured as umol/L] from baseline to week 48 is presented as ratio to baseline. Outcome measure was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (week 55); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. | FAS included all randomised participants. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total bilirubin | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period. | Safety analysis set included all participants that received at least one dose of randomised treatment. | Posted | | Number | | Events | | From baseline (week 0) to week 55 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Number of Treatment-Emergent Hypoglycaemic Episodes | Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L [70 milligrams per decilitre (mg/dL)] Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period. | Safety analysis set included all participants that received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants with type 2 diabetes who contributed to the analysis | Posted | | Number | | Episodes | | From baseline (week 0) to week 55 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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| Secondary | Change From Baseline in Pulse | Change in pulse from baseline to week 48 is presented. Outcome measure was evaluated based on data from on-treatment period which started on the date of first administration of trial product and ended on the date of whatever comes first of: a) last dose of trial product + 49 days (7 half-lives of semaglutide), b) follow-up visit (week 55), or c) end of the in-trial period. | Safety analysis set included all participants that received at least one dose of randomised treatment. Overall number of participants analysed = Number of participants who contributed to the analysis | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline (week 0), Week 48 | | | | ID | Title | Description |
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| OG000 | Semaglutide 2.4 mg | Participants were to receive once weekly subcutaneous (s.c.) injection of semaglutide for 48 weeks. Participants initially received 0.24 milligrams (mg) of semaglutide and the dose was then escalated once in 4 weeks until the target dose of 2.4 mg was reached: 0.24 mg (week 1 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 16 to week 48). | | OG001 | Placebo | Participants were to receive once weekly s.c. injection of placebo matched to semaglutide (0.24 mg, 0.5 mg, 1.0 mg, 1.7 mg or 2.4 mg) for 48 weeks. |
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