A Research Study to Find Out How Semaglutide Works in the... | NCT04865770

NCT04865770

ID	Type	Description	Link
U1111-1248-7912	Other Identifier	World Health Organization (WHO)
2020-000828-19	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Semaglutide 1.0 mg OW	Experimental	Once-weekly (OW) Semaglutide administered subcutaneously (s.c., under the skin).	Drug: Semaglutide
Placebo (Semaglutide) 1.0 mg OW	Placebo Comparator	Once-weekly (OW) placebo (Semaglutide) administered subcutaneously (s.c., under the skin).	Drug: Placebo (Semaglutide)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Semaglutide	Drug	Semaglutide given subcutaneously (sc, under the skin) once weekly. Dose gradually increased over 8 weeks from 0.25 to 1.0 mg. The study will last for about 1 year.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)	Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation.	Baseline (week 0), End of treatment (week 52)
Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)	Change in kidney oxygenation in medulla assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation.	Baseline (week 0), End of treatment (week 52)
Change in Global Kidney Perfusion (MRI)	Change in global kidney perfusion assessed by phase contrast MRI from baseline (week 0) to end of treatment (week 52) is presented.	Baseline (week 0), End of treatment (week 52)
Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)	Change in kidney inflammation in cortex assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.	Baseline (week 0), End of treatment (week 52)
Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)	Change in kidney inflammation in medulla assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.	Baseline (week 0), End of treatment (week 52)

Secondary Outcomes

Measure	Description	Time Frame
Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)	Changes in gene expression were assessed by single nucleus RNA sequencing (kidney biopsies) from baseline (week 0) to end of treatment (week 52). Cell type annotation was performed prior to the analysis. The analysis reports the log2 fold change in form of differential gene expression per cell type from baseline, comparing treatment arms. Genes are considered significant if fold change > 0.5 or < 0.5 and false discovery rate (FDR) <0.1; these criteria help identify biologically significant genes that are reliably differentially expressed in patients with conditions such as Type 2 diabetes and chronic kidney disease. The differential expression was estimated using a linear mixed model that included participant as a random effect. The cell types presented are those that contain these differentially expressed genes demonstrating the treatment response. This threshold is based on findings published in cross-sectional observational studies related to disease impact and gene activity.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female.
Age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
HbA1c (glycated haemoglobin) below or equal to 9.0 percent (below or equal to 75 mmol/mol).
Depending on biopsy/non-biopsy population:
1. For subjects in the non-biopsy population: Serum creatinine-based eGFR greater than or equal to 30 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
2. For subjects in the biopsy sub-population: Serum creatinine-based eGFR greater than or equal to 40 and below or equal to 75 mL/min/1.73 m^2(CKD-EPI).
UACR ( Urinary albumin-to-creatinine ratio ) greater than or equal to 20 and below 5000 mg/g.
Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)) unless such treatment is contraindicated or not tolerated.Treatment dose must be stable for at least 28 days prior to screening.

Exclusion Criteria:

Use of any glucagon-like peptide 1 receptor agonist (GLP-1 RA) within 30 days prior to screening.
A prior solid organ transplant or awaiting solid organ transplant.
Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
Presence or history of malignant neoplasms (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening.
Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and Visit 2. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Treatment with systemic anti-inflammatory or immunosuppressant drugs within 90 days prior to screening. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed.
Any contraindication for MRI according to standard checklist used in clinical routine, including claustrophobia or metallic foreign bodies, metallic implants, internal electrical devices, or permanent makeup/tattoos that cannot be declared MR compatible.
Combination use of an ACE (angiotensin-converting enzyme) inhibitor and an ARB (angiotensin II receptor blockers).

Contacts/Locations Module

Name	Affiliation	Role
Clinical Transparency (Dept.2834)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona-CaTs		Tucson	Arizona	85724	United States
Academic Medical Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41207620	Derived	Pruijm M, Belmar N, Bjornstad P, Cherney DZI, Das V, Gunnarsson T, Hodgin JB, Schytz PA, Tuttle KR, Kretzler M. REMODELing mechanistic trials for kidney disease: a multimodal, tissue-centered approach to understand the renal mechanism of action of semaglutide. Kidney Int. 2026 Jan;109(1):6-16. doi: 10.1016/j.kint.2025.10.005. Epub 2025 Nov 7.
39963952

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 21, 2022	Nov 20, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Semaglutide 1.0 mg OW

Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.

Arm/Group Information

ID	Title	Description
BG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
BG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00065.4± 9.2 BG00165.1± 11.3 BG00265.3± 9.9

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG0019 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0013 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian Or Alaska Native	BG0002 BG0010 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Kidney Oxygenation (Cortex), Blood Oxygenation-level Dependent Magnetic Resonance Imaging (BOLD MRI) (R2*)

Change in kidney oxygenation in cortex assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation.

Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed= FAS. Number Analyzed= number of participants with available data for particular timepoint, for the respective arms.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of kidney oxygenation (cortex)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants	OG00071 OG00135

Title

Denominators

Categories

Bilateral cortex

- ParticipantsOG00058
- ParticipantsOG00133

Title	Measurements
	OG0000.98± 5.35

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
OG000 OG001	Bilateral cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.	ANCOVA		0.1333		Treatment ratio	0.98			2-Sided	95	0.96	1.01					Other
OG000 OG001

Primary

Change in Kidney Oxygenation (Medulla), BOLD MRI (R2*)

Change in kidney oxygenation in medulla assessed by BOLD (blood oxygenation level dependent) MRI from baseline (week 0) to end of treatment (week 52) is presented. R2* is a measure used in BOLD MRI to indicate the level of tissue oxygenation. A higher R2* value means lower tissue oxygenation while a lower R2* value means higher tissue oxygenation.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of kidney oxygenation (medulla)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Primary

Change in Global Kidney Perfusion (MRI)

Change in global kidney perfusion assessed by phase contrast MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of global kidney perfusion

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Primary

Change in Kidney Inflammation (Cortex), Longitudinal Relaxation Time (T1) Mapping (MRI)

Change in kidney inflammation in cortex assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of kidney inflammation (cortex)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts

Primary

Change in Kidney Inflammation (Medulla), T1 Mapping (MRI)

Change in kidney inflammation in medulla assessed by T1 mapping MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of kidney inflammation (medulla)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Gene Expression Assessed by Single Nucleus Ribonucleic Acid (RNA) Sequencing (Kidney Biopsy)

Changes in gene expression were assessed by single nucleus RNA sequencing (kidney biopsies) from baseline (week 0) to end of treatment (week 52). Cell type annotation was performed prior to the analysis. The analysis reports the log2 fold change in form of differential gene expression per cell type from baseline, comparing treatment arms. Genes are considered significant if fold change > 0.5 or < 0.5 and false discovery rate (FDR) <0.1; these criteria help identify biologically significant genes that are reliably differentially expressed in patients with conditions such as Type 2 diabetes and chronic kidney disease. The differential expression was estimated using a linear mixed model that included participant as a random effect. The cell types presented are those that contain these differentially expressed genes demonstrating the treatment response. This threshold is based on findings published in cross-sectional observational studies related to disease impact and gene activity.

Full analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall Number participants analyzed = number of participants with available data for particular timepoint, for the respective arms.

Posted

Number

log2 fold-change

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg/Placebo	Participants received OW treatment with 0.25 mg semaglutide or placebo from week 0 to week 4 followed by 0.5 mg semaglutide or placebo from week 4 to week 8 followed by 1 mg semaglutide or placebo from week 8 to week 52 depending on the arm they were randomised to. This arm has combined data from Semaglutide arm and Placebo arm.

Secondary

Change in Glomerular Basement Membrane Width (Kidney Biopsy)

Change in glomerular basement membrane width assessed in kidney biopsy from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Mean

Standard Deviation

Nanometer (nm)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Apparent Diffusion Coefficient (ADC) (Cortex) (MRI)

Change in apparent diffusion coefficient in cortex assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of ADC (cortex)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Apparent Diffusion Coefficient (ADC) (Medulla) (MRI)

Change in apparent diffusion coefficient in medulla assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of ADC (medulla)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Mean Renal Artery Resistive Index (RARI) (MRI)

Change in renal arterial resistive index assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented. RARI measures the preservation of blood flow in renal arteries throughout the cardiac cycle and is therefore a measure for resistance of blood flow within the renal arteries. It serves as an indicator of kidney vascular health and potential arterial stiffness or obstruction. It is prognostic for primary cardiovascular and renal events in type 2 diabetes, where a lower RARI predicts a lower rate of events. RARI is calculated by relating the difference between blood flow at maximum velocity during the cardiac contraction phase (peak systolic velocity, PSV) and the speed at the end of the relaxation phase, at the point of minimal velocity (end diastolic velocity, EDV) with PSV, i.e., RARI = (PSV-EDV)/PSV.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of RARI

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.

Secondary

Change in Mean Arterial Flow (MRI)

Change in mean arterial flow assessed by MRI from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Geometric Mean

Geometric Coefficient of Variation

Ratio of mean arterial flow

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Natriuresis (Urinary Sodium Excretion) (Urinalysis)

Change in natriuresis (urinary sodium excretion) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Mean

Standard Deviation

Millimoles per day (mmol/day)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Albumin Excretion Rate (Urinalysis)

Change in albumin excretion rate (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Mean

Standard Deviation

Milligrams per day (mg/d)

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Secondary

Change in Kidney Function (Creatinine Clearance) (Urinalysis)

Change in kidney function (creatinine clearance) (urinalysis) from baseline (week 0) to end of treatment (week 52) is presented.

Posted

Mean

Standard Deviation

Milliliter per minute

Baseline (week 0), End of treatment (week 52)

ID	Title	Description
OG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.
OG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Semaglutide 1.0 mg	Participants received once-weekly (OW) subcutaneous (s. c.) injection of semaglutide for 52 weeks. Participants received a dose of 0.25 milligrams (mg) from week 0 to week 4, then the dose was increased to 0.5 mg from week 4 to week 8. From week 8 to week 52, the dosage was 1.0 mg.	2	71	14	71	15	71
EG001	Placebo	Participants received once-weekly (OW) subcutaneous injection (s. c.) of placebo matched for semaglutide for 52 weeks.	1	35	5	35	11	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected71 at risk EG0010 events0 affected35 at risk
Anger	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Blood creatinine increased	Investigations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Death	General disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0011 events1 affected35 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0011 events1 affected35 at risk
Osteomyelitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0011 events1 affected35 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0011 events1 affected35 at risk
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Suicide attempt	Psychiatric disorders	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0010 events0 affected35 at risk
Urinary retention	Renal and urinary disorders	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0011 events1 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected71 at risk EG0010 events0 affected35 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected71 at risk EG0010 events0 affected35 at risk
Diabetic retinopathy	Eye disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected71 at risk EG0012 events2 affected35 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0004 events4 affected71 at risk EG0015 events4 affected35 at risk
Nasopharyngitis	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0000 events0 affected71 at risk EG0012 events2 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA 27.1	Systematic Assessment	EG0005 events4 affected71 at risk EG0012 events2 affected35 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 27.1	Systematic Assessment	EG0001 events1 affected71 at risk EG0012 events2 affected35 at risk

First MCP Posted Date

ID	Term
D003924	Diabetes Mellitus, Type 2
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
C000591245	semaglutide

Right cortex: Responses are analysed using an ANCOVA with actual treatment, region and the stratification factors as categorical effects and the baseline value as a covariate, on log scale.

Units	Counts
Participants	OG00071 OG00135