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Delfa

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CompletedPhase 2Results posted

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

77

Recruiting sites

-

Actual enrollment

415

Study population

Type 2 diabetes

Eligibility highlights

HbA1c 7-10%

Primary endpoint

HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00696657
Org study IDNN9535-1821
Secondary ID2007-003956-12

Timeline

Milestones

Study start2008-06-03actual
Study first posted2008-06-13estimated
Primary completion2009-02-05actual
Study completion2009-02-05actual
Results first posted2018-09-12actual
Last update posted2019-08-14actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
HbA1c: 7.0-10.0 % (both inclusive)
Body weight between 60 kg and 110 kg

Exclusion criteria

Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
Impaired liver or kidney function
Proliferative retinopathy or maculopathy requiring acute treatment
Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
Recurrent major hypoglycaemia or hypoglycaemic unawareness
Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Endpoints (70)

What's being measured

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

Coverage by outcome category

Safety / tolerability / PK
58
Cardiometabolic biomarkers
6
MASH / liver
4
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Primary/registry result

HbA1c

Time frame:After 12 weeks of treatment.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · Percentage (%) of HbA1c95% CI
Placebo-0.5-
Semaglutide 0.1 mg-0.6-
Semaglutide 0.2 mg-0.9-
Semaglutide 0.4 mg-1.0-
Semaglutide 0.8 mg-1.4-
Semaglutide 0.8 mg (With Titration)-1.4-
Semaglutide 1.6 mg (With Titration)-1.5-
Liraglutide 1.2 mg-1.1-
Liraglutide 1.8 mg-1.3-
Estimated treatment differences-1.1995% CI-1.58 - -0.80p<0.0001ANOVA
Estimated treatment differences-0.9595% CI-1.33 - -0.57p<0.0001ANOVA
Estimated treatment differences-0.9795% CI-1.35 - -0.59p<0.0001ANOVA
Estimated treatment differences-0.6195% CI-0.98 - -0.23p0.0002ANOVA
Estimated treatment differences-0.4195% CI-0.79 - -0.02p0.0324ANOVA
Estimated treatment differences-0.0995% CI-0.46 - 0.28p0.9772ANOVA
Estimated treatment differences-0.3595% CI-0.64 - -0.06ANOVA
Estimated treatment differences-0.1195% CI-0.39 - 0.18ANOVA
Estimated treatment differences-0.1395% CI-0.42 - 0.16ANOVA
Estimated treatment differences0.2495% CI-0.05 - 0.52ANOVA
Estimated treatment differences0.4495% CI0.15 - 0.73ANOVA
Estimated treatment differences0.7595% CI0.48 - 1.03ANOVA
Estimated treatment differences-0.8495% CI-1.12 - -0.56ANOVA
Estimated treatment differences-0.5195% CI-0.80 - -0.22ANOVA
Estimated treatment differences-0.2795% CI-0.56 - 0.02ANOVA
Estimated treatment differences-0.2995% CI-0.58 - 0.01ANOVA
Estimated treatment differences0.0895% CI-0.22 - 0.37ANOVA
Estimated treatment differences0.2895% CI-0.02 - 0.57ANOVA
Estimated treatment differences0.5995% CI0.31 - 0.88ANOVA
Estimated treatment differences-0.6895% CI-0.97 - -0.40ANOVA
Primary/protocol endpoint

HbA1c

Time frame:After 12 weeks of treatment.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

4 endpoints
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)

Time frame:Week 0, week 12.

AST, change

change from baseline, improvement

LOINC 1920-8

Posted result

GroupMean · U/L95% CI
Placebo-1.09-
Semaglutide 0.1 mg1.23-
Semaglutide 0.2 mg0.24-
Semaglutide 0.4 mg-1.81-
Semaglutide 0.8 mg-0.37-
Semaglutide 0.8 mg (With Titration)-2.60-
Semaglutide 1.6 mg (With Titration)-4.07-
Liraglutide 1.2 mg-0.16-
Liraglutide 1.8 mg-2.13-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)

Time frame:Week 0, week 12.

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

GroupMean · U/L95% CI
Placebo-2.41-
Semaglutide 0.1 mg0.83-
Semaglutide 0.2 mg0.68-
Semaglutide 0.4 mg-4.21-
Semaglutide 0.8 mg-2.13-
Semaglutide 0.8 mg (With Titration)-6.19-
Semaglutide 1.6 mg (With Titration)-6.55-
Liraglutide 1.2 mg-0.88-
Liraglutide 1.8 mg-1.83-
Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)

Time frame:Week 0, week 12.

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)

Time frame:Week 0, week 12.

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

6 endpoints
Secondary/registry result

Change From Baseline in Vital Signs (Pulse)

Time frame:Week 0, week 12

Heart rate, change

change from baseline, improvement

Posted result

GroupMean · Beats/minute95% CI
Placebo0.5-
Semaglutide 0.1 mg-0.0-
Semaglutide 0.2 mg0.5-
Semaglutide 0.4 mg1.5-
Semaglutide 0.8 mg1.5-
Semaglutide 0.8 mg (With Titration)2.9-
Semaglutide 1.6 mg (With Titration)3.9-
Liraglutide 1.2 mg4.4-
Liraglutide 1.8 mg2.1-
Secondary/registry result

Change From Baseline in Vital Signs (Blood Pressure; SBP)

Time frame:Week 0, week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupMean · mmHg95% CI
Placebo-3.2-
Semaglutide 0.1 mg3.3-
Semaglutide 0.2 mg-2.5-
Semaglutide 0.4 mg-3.6-
Semaglutide 0.8 mg-6.7-
Semaglutide 0.8 mg (With Titration)-7.7-
Semaglutide 1.6 mg (With Titration)-5.9-
Liraglutide 1.2 mg-2.9-
Liraglutide 1.8 mg-5.4-
Secondary/registry result

Change From Baseline in Vital Signs (Blood Pressure; DBP)

Time frame:Week 0, week 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupMean · mmHg95% CI
Placebo-2.3-
Semaglutide 0.1 mg1.5-
Semaglutide 0.2 mg-0.4-
Semaglutide 0.4 mg-1.5-
Semaglutide 0.8 mg-1.5-
Semaglutide 0.8 mg (With Titration)-2.3-
Semaglutide 1.6 mg (With Titration)-3.0-
Liraglutide 1.2 mg-2.1-
Liraglutide 1.8 mg-0.0-
Secondary/protocol endpoint

Change From Baseline in Vital Signs (Pulse)

Time frame:Week 0, week 12

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Vital Signs (Blood Pressure; SBP)

Time frame:Week 0, week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Vital Signs (Blood Pressure; DBP)

Time frame:Week 0, week 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

58 endpoints
Secondary/registry result

Percentage of Subjects With an Adverse Events

Time frame:After 12 weeks of treatment.

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

GroupNumber · Percentage (%) of subjects95% CI
Placebo43.5-
Semaglutide 0.1 mg59.6-
Semaglutide 0.2 mg55.8-
Semaglutide 0.4 mg72.9-
Semaglutide 0.8 mg85.7-
Semaglutide 0.8 mg (With Titration)72.1-
Semaglutide 1.6 mg (With Titration)93.6-
Liraglutide 1.2 mg55.6-
Liraglutide 1.8 mg62.0-
Secondary/registry result

Percentage of Subjects With Hypoglycaemic Episode

Time frame:After 12 weeks of treatment

Documented hypoglycemia

threshold achievement, event

Posted result

GroupNumber · Percentage (%) of subjects95% CI
PlaceboMajor0-
Minor0-
Symptoms only2.2-
Semaglutide 0.1 mgMajor0-
Minor4.3-
Symptoms only2.1-
Semaglutide 0.2 mgMajor0-
Minor0-
Symptoms only2.3-
Semaglutide 0.4 mgMajor0-
Minor4.2-
Symptoms only0-
Semaglutide 0.8 mgMajor0-
Minor0-
Symptoms only0-
Semaglutide 0.8 mg (With Titration)Major0-
Minor2.3-
Symptoms only0-
Semaglutide 1.6 mg (With Titration)Major0-
Minor0-
Symptoms only6.4-
Liraglutide 1.2 mgMajor0-
Minor4.4-
Symptoms only8.9-
Liraglutide 1.8 mgMajor0-
Minor2.0-
Symptoms only2.0-
Secondary/registry result

Change From Baseline in ECG

Time frame:Week 0, week 12.

categorical status, descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek -2: Normal42-
Week -2: Abnormal, NCS4-
Week -2: Abnormal, CS0-
Week 12: Normal39-
Week 12: Abnormal, NCS6-
Week 12: Abnormal, CS0-
Week 12: ECG not done (ND)1-
Semaglutide 0.1 mgWeek -2: Normal33-
Week -2: Abnormal, NCS14-
Week -2: Abnormal, CS0-
Week 12: Normal32-
Week 12: Abnormal, NCS14-
Week 12: Abnormal, CS0-
Week 12: ECG not done (ND)1-
Semaglutide 0.2 mgWeek -2: Normal37-
Week -2: Abnormal, NCS6-
Week -2: Abnormal, CS0-
Week 12: Normal34-
Week 12: Abnormal, NCS3-
Week 12: Abnormal, CS1-
Week 12: ECG not done (ND)5-
Semaglutide 0.4 mgWeek -2: Normal34-
Week -2: Abnormal, NCS12-
Week -2: Abnormal, CS2-
Week 12: Normal36-
Week 12: Abnormal, NCS7-
Week 12: Abnormal, CS2-
Week 12: ECG not done (ND)1-
Semaglutide 0.8 mgWeek -2: Normal31-
Week -2: Abnormal, NCS10-
Week -2: Abnormal, CS1-
Week 12: Normal29-
Week 12: Abnormal, NCS7-
Week 12: Abnormal, CS1-
Week 12: ECG not done (ND)3-
Semaglutide 0.8 mg (With Titration)Week -2: Normal28-
Week -2: Abnormal, NCS15-
Week -2: Abnormal, CS0-
Week 12: Normal33-
Week 12: Abnormal, NCS9-
Week 12: Abnormal, CS0-
Week 12: ECG not done (ND)1-
Semaglutide 1.6 mg (With Titration)Week -2: Normal37-
Week -2: Abnormal, NCS8-
Week -2: Abnormal, CS2-
Week 12: Normal36-
Week 12: Abnormal, NCS5-
Week 12: Abnormal, CS3-
Week 12: ECG not done (ND)2-
Liraglutide 1.2 mgWeek -2: Normal39-
Week -2: Abnormal, NCS6-
Week -2: Abnormal, CS0-
Week 12: Normal37-
Week 12: Abnormal, NCS6-
Week 12: Abnormal, CS0-
Week 12: ECG not done (ND)2-
Liraglutide 1.8 mgWeek -2: Normal41-
Week -2: Abnormal, NCS9-
Week -2: Abnormal, CS0-
Week 12: Normal42-
Week 12: Abnormal, NCS5-
Week 12: Abnormal, CS0-
Week 12: ECG not done (ND)2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo-0.0-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.0-
Semaglutide 0.4 mg0.0-
Semaglutide 0.8 mg-0.0-
Semaglutide 0.8 mg (With Titration)-0.0-
Semaglutide 1.6 mg (With Titration)-0.0-
Liraglutide 1.2 mg0.0-
Liraglutide 1.8 mg0.0-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo-0.0-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.0-
Semaglutide 0.4 mg0.0-
Semaglutide 0.8 mg-0.0-
Semaglutide 0.8 mg (With Titration)0.0-
Semaglutide 1.6 mg (With Titration)0.1-
Liraglutide 1.2 mg0.0-
Liraglutide 1.8 mg-0.0-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Litre/litre (L/L)95% CI
Placebo-0.01-
Semaglutide 0.1 mg-0.01-
Semaglutide 0.2 mg-0.01-
Semaglutide 0.4 mg0.00-
Semaglutide 0.8 mg-0.01-
Semaglutide 0.8 mg (With Titration)-0.00-
Semaglutide 1.6 mg (With Titration)-0.00-
Liraglutide 1.2 mg0.00-
Liraglutide 1.8 mg-0.01-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Gram/litre (g/L)95% CI
Placebo0.1-
Semaglutide 0.1 mg-0.4-
Semaglutide 0.2 mg-1.2-
Semaglutide 0.4 mg2.8-
Semaglutide 0.8 mg-0.3-
Semaglutide 0.8 mg (With Titration)1.5-
Semaglutide 1.6 mg (With Titration)1.0-
Liraglutide 1.2 mg2.1-
Liraglutide 1.8 mg1.1-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo-0.1-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.1-
Semaglutide 0.4 mg0.2-
Semaglutide 0.8 mg-0.0-
Semaglutide 0.8 mg (With Titration)-0.1-
Semaglutide 1.6 mg (With Titration)0.1-
Liraglutide 1.2 mg0.0-
Liraglutide 1.8 mg-0.1-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo0.1-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.0-
Semaglutide 0.4 mg0.1-
Semaglutide 0.8 mg0.1-
Semaglutide 0.8 mg (With Titration)0.0-
Semaglutide 1.6 mg (With Titration)0.1-
Liraglutide 1.2 mg0.1-
Liraglutide 1.8 mg0.1-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo0.1-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.1-
Semaglutide 0.4 mg0.3-
Semaglutide 0.8 mg-0.1-
Semaglutide 0.8 mg (With Titration)0.5-
Semaglutide 1.6 mg (With Titration)0.5-
Liraglutide 1.2 mg0.3-
Liraglutide 1.8 mg0.3-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo9.0-
Semaglutide 0.1 mg16.1-
Semaglutide 0.2 mg10.8-
Semaglutide 0.4 mg10.7-
Semaglutide 0.8 mg5.4-
Semaglutide 0.8 mg (With Titration)5.5-
Semaglutide 1.6 mg (With Titration)15.9-
Liraglutide 1.2 mg10.1-
Liraglutide 1.8 mg16.7-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Trillion cells/litre (10^12/L)95% CI
Placebo-0.04-
Semaglutide 0.1 mg-0.06-
Semaglutide 0.2 mg-0.03-
Semaglutide 0.4 mg0.08-
Semaglutide 0.8 mg-0.05-
Semaglutide 0.8 mg (With Titration)0.03-
Semaglutide 1.6 mg (With Titration)0.04-
Liraglutide 1.2 mg0.04-
Liraglutide 1.8 mg0.02-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Posted result

GroupMean · Billion cells/litre (10^9/L)95% CI
Placebo0.05-
Semaglutide 0.1 mg0.04-
Semaglutide 0.2 mg-0.16-
Semaglutide 0.4 mg0.59-
Semaglutide 0.8 mg0.14-
Semaglutide 0.8 mg (With Titration)0.41-
Semaglutide 1.6 mg (With Titration)0.70-
Liraglutide 1.2 mg0.40-
Liraglutide 1.8 mg0.26-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · g/L95% CI
Placebo0.402-
Semaglutide 0.1 mg0.130-
Semaglutide 0.2 mg-0.091-
Semaglutide 0.4 mg-0.177-
Semaglutide 0.8 mg0.303-
Semaglutide 0.8 mg (With Titration)0.607-
Semaglutide 1.6 mg (With Titration)0.271-
Liraglutide 1.2 mg0.916-
Liraglutide 1.8 mg0.846-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · U/L95% CI
Placebo-0.52-
Semaglutide 0.1 mg-1.66-
Semaglutide 0.2 mg-2.37-
Semaglutide 0.4 mg-2.35-
Semaglutide 0.8 mg-1.39-
Semaglutide 0.8 mg (With Titration)-2.81-
Semaglutide 1.6 mg (With Titration)-3.98-
Liraglutide 1.2 mg-1.89-
Liraglutide 1.8 mg-4.25-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · umol/L95% CI
Placebo0.7-
Semaglutide 0.1 mg-0.4-
Semaglutide 0.2 mg0.6-
Semaglutide 0.4 mg0.8-
Semaglutide 0.8 mg0.7-
Semaglutide 0.8 mg (With Titration)1.3-
Semaglutide 1.6 mg (With Titration)0.4-
Liraglutide 1.2 mg-0.5-
Liraglutide 1.8 mg0.2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Placebo0.0-
Semaglutide 0.1 mg-0.0-
Semaglutide 0.2 mg-0.0-
Semaglutide 0.4 mg-0.0-
Semaglutide 0.8 mg0.0-
Semaglutide 0.8 mg (With Titration)0.0-
Semaglutide 1.6 mg (With Titration)-0.0-
Liraglutide 1.2 mg-0.0-
Liraglutide 1.8 mg0.0-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Placebo0.00-
Semaglutide 0.1 mg-0.01-
Semaglutide 0.2 mg-0.04-
Semaglutide 0.4 mg-0.01-
Semaglutide 0.8 mg-0.01-
Semaglutide 0.8 mg (With Titration)0.01-
Semaglutide 1.6 mg (With Titration)-0.02-
Liraglutide 1.2 mg-0.02-
Liraglutide 1.8 mg-0.01-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · umol/L95% CI
Placebo-1.02-
Semaglutide 0.1 mg0.936-
Semaglutide 0.2 mg-0.349-
Semaglutide 0.4 mg-2.31-
Semaglutide 0.8 mg-0.658-
Semaglutide 0.8 mg (With Titration)-1.67-
Semaglutide 1.6 mg (With Titration)2.089-
Liraglutide 1.2 mg0.841-
Liraglutide 1.8 mg-0.917-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Placebo0.07-
Semaglutide 0.1 mg0.08-
Semaglutide 0.2 mg0.06-
Semaglutide 0.4 mg-0.02-
Semaglutide 0.8 mg0.04-
Semaglutide 0.8 mg (With Titration)-0.02-
Semaglutide 1.6 mg (With Titration)-0.07-
Liraglutide 1.2 mg0.10-
Liraglutide 1.8 mg-0.12-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Placebo0.1-
Semaglutide 0.1 mg0.0-
Semaglutide 0.2 mg-0.1-
Semaglutide 0.4 mg-0.1-
Semaglutide 0.8 mg0.4-
Semaglutide 0.8 mg (With Titration)0.2-
Semaglutide 1.6 mg (With Titration)0.5-
Liraglutide 1.2 mg0.7-
Liraglutide 1.8 mg0.6-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)

Time frame:Week 0, week 12.

change from baseline, descriptive

Posted result

GroupMean · mmol/L95% CI
Placebo-0.1-
Semaglutide 0.1 mg0.1-
Semaglutide 0.2 mg-0.1-
Semaglutide 0.4 mg-0.4-
Semaglutide 0.8 mg-0.3-
Semaglutide 0.8 mg (With Titration)-0.5-
Semaglutide 1.6 mg (With Titration)-0.5-
Liraglutide 1.2 mg-0.1-
Liraglutide 1.8 mg-0.4-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)

Time frame:Week 0, week 12

categorical status, descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek 0: Negative31-
Week 0: Positive13-
Week 0: >=55 mmol/L1-
Week 0: Missing1-
Week 12: Negative34-
Week 12: Positive8-
Week 12: >=55 mmol/L2-
Week 12: Missing0-
Semaglutide 0.1 mgWeek 0: Negative26-
Week 0: Positive18-
Week 0: >=55 mmol/L3-
Week 0: Missing0-
Week 12: Negative28-
Week 12: Positive15-
Week 12: >=55 mmol/L2-
Week 12: Missing1-
Semaglutide 0.2 mgWeek 0: Negative23-
Week 0: Positive15-
Week 0: >=55 mmol/L5-
Week 0: Missing0-
Week 12: Negative28-
Week 12: Positive8-
Week 12: >=55 mmol/L3-
Week 12: Missing2-
Semaglutide 0.4 mgWeek 0: Negative35-
Week 0: Positive11-
Week 0: >=55 mmol/L2-
Week 0: Missing0-
Week 12: Negative35-
Week 12: Positive8-
Week 12: >=55 mmol/L1-
Week 12: Missing1-
Semaglutide 0.8 mgWeek 0: Negative23-
Week 0: Positive15-
Week 0: >=55 mmol/L3-
Week 0: Missing0-
Week 12: Negative30-
Week 12: Positive2-
Week 12: >=55 mmol/L2-
Week 12: Missing3-
Semaglutide 0.8 mg (With Titration)Week 0: Negative28-
Week 0: Positive10-
Week 0: >=55 mmol/L3-
Week 0: Missing2-
Week 12: Negative39-
Week 12: Positive1-
Week 12: >=55 mmol/L0-
Week 12: Missing1-
Semaglutide 1.6 mg (With Titration)Week 0: Negative32-
Week 0: Positive12-
Week 0: >=55 mmol/L2-
Week 0: Missing1-
Week 12: Negative39-
Week 12: Positive3-
Week 12: >=55 mmol/L0-
Week 12: Missing1-
Liraglutide 1.2 mgWeek 0: Negative30-
Week 0: Positive10-
Week 0: >=55 mmol/L3-
Week 0: Missing2-
Week 12: Negative35-
Week 12: Positive7-
Week 12: >=55 mmol/L1-
Week 12: Missing0-
Liraglutide 1.8 mgWeek 0: Negative22-
Week 0: Positive20-
Week 0: >=55 mmol/L5-
Week 0: Missing3-
Week 12: Negative39-
Week 12: Positive6-
Week 12: >=55 mmol/L0-
Week 12: Missing2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)

Time frame:Week 0, week 12

categorical status, descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek 0: Negative45-
Week 0: Trace0-
Week 0: Small0-
Week 0: Moderate0-
Week 0: Missing1-
Week 12: Negative42-
Week 12: Trace0-
Week 12: Small1-
Week 12: Large1-
Week 12: Missing0-
Semaglutide 0.1 mgWeek 0: Negative45-
Week 0: Trace2-
Week 0: Small0-
Week 0: Moderate0-
Week 0: Missing0-
Week 12: Negative45-
Week 12: Trace0-
Week 12: Small0-
Week 12: Large0-
Week 12: Missing1-
Semaglutide 0.2 mgWeek 0: Negative41-
Week 0: Trace1-
Week 0: Small1-
Week 0: Moderate0-
Week 0: Missing0-
Week 12: Negative38-
Week 12: Trace1-
Week 12: Small0-
Week 12: Large0-
Week 12: Missing2-
Semaglutide 0.4 mgWeek 0: Negative45-
Week 0: Trace1-
Week 0: Small0-
Week 0: Moderate2-
Week 0: Missing0-
Week 12: Negative42-
Week 12: Trace2-
Week 12: Small0-
Week 12: Large0-
Week 12: Missing1-
Semaglutide 0.8 mgWeek 0: Negative38-
Week 0: Trace2-
Week 0: Small0-
Week 0: Moderate1-
Week 0: Missing0-
Week 12: Negative30-
Week 12: Trace1-
Week 12: Small2-
Week 12: Large1-
Week 12: Missing3-
Semaglutide 0.8 mg (With Titration)Week 0: Negative39-
Week 0: Trace1-
Week 0: Small1-
Week 0: Moderate0-
Week 0: Missing2-
Week 12: Negative38-
Week 12: Trace1-
Week 12: Small0-
Week 12: Large1-
Week 12: Missing1-
Semaglutide 1.6 mg (With Titration)Week 0: Negative43-
Week 0: Trace2-
Week 0: Small1-
Week 0: Moderate0-
Week 0: Missing1-
Week 12: Negative39-
Week 12: Trace2-
Week 12: Small1-
Week 12: Large0-
Week 12: Missing1-
Liraglutide 1.2 mgWeek 0: Negative43-
Week 0: Trace0-
Week 0: Small0-
Week 0: Moderate0-
Week 0: Missing2-
Week 12: Negative43-
Week 12: Trace0-
Week 12: Small0-
Week 12: Large0-
Week 12: Missing0-
Liraglutide 1.8 mgWeek 0: Negative45-
Week 0: Trace1-
Week 0: Small1-
Week 0: Moderate0-
Week 0: Missing3-
Week 12: Negative44-
Week 12: Trace1-
Week 12: Small0-
Week 12: Large0-
Week 12: Missing2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)

Time frame:Week 0, week 12

descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek 0: Negative45-
Week 0: Positive0-
Week 0: Missing1-
Week 12: Negative43-
Week 12: Positive1-
Week 12: Missing0-
Semaglutide 0.1 mgWeek 0: Negative47-
Week 0: Positive0-
Week 0: Missing0-
Week 12: Negative44-
Week 12: Positive1-
Week 12: Missing1-
Semaglutide 0.2 mgWeek 0: Negative39-
Week 0: Positive4-
Week 0: Missing0-
Week 12: Negative35-
Week 12: Positive4-
Week 12: Missing2-
Semaglutide 0.4 mgWeek 0: Negative46-
Week 0: Positive2-
Week 0: Missing0-
Week 12: Negative44-
Week 12: Positive0-
Week 12: Missing1-
Semaglutide 0.8 mgWeek 0: Negative41-
Week 0: Positive0-
Week 0: Missing0-
Week 12: Negative34-
Week 12: Positive0-
Week 12: Missing3-
Semaglutide 0.8 mg (With Titration)Week 0: Negative41-
Week 0: Positive0-
Week 0: Missing2-
Week 12: Negative40-
Week 12: Positive0-
Week 12: Missing1-
Semaglutide 1.6 mg (With Titration)Week 0: Negative45-
Week 0: Positive1-
Week 0: Missing1-
Week 12: Negative38-
Week 12: Positive4-
Week 12: Missing1-
Liraglutide 1.2 mgWeek 0: Negative42-
Week 0: Positive1-
Week 0: Missing2-
Week 12: Negative41-
Week 12: Positive2-
Week 12: Missing0-
Liraglutide 1.8 mgWeek 0: Negative46-
Week 0: Positive1-
Week 0: Missing3-
Week 12: Negative43-
Week 12: Positive2-
Week 12: Missing2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)

Time frame:Week 0, week 12

descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek 0: 6.016-
Week 0: 6.513-
Week 0: 7.011-
Week 0: 7.54-
Week 0: 8.00-
Week 0: >=8.51-
Week 0: Missing1-
Week 12: 6.011-
Week 12: 6.515-
Week 12: 7.015-
Week 12: 7.53-
Week 12: 8.00-
Week 12: >=8.50-
Week 12: Missing0-
Semaglutide 0.1 mgWeek 0: 6.013-
Week 0: 6.518-
Week 0: 7.012-
Week 0: 7.53-
Week 0: 8.00-
Week 0: >=8.51-
Week 0: Missing0-
Week 12: 6.014-
Week 12: 6.514-
Week 12: 7.013-
Week 12: 7.52-
Week 12: 8.01-
Week 12: >=8.51-
Week 12: Missing1-
Semaglutide 0.2 mgWeek 0: 6.019-
Week 0: 6.515-
Week 0: 7.08-
Week 0: 7.50-
Week 0: 8.01-
Week 0: >=8.50-
Week 0: Missing0-
Week 12: 6.019-
Week 12: 6.59-
Week 12: 7.06-
Week 12: 7.54-
Week 12: 8.01-
Week 12: >=8.50-
Week 12: Missing2-
Semaglutide 0.4 mgWeek 0: 6.011-
Week 0: 6.521-
Week 0: 7.010-
Week 0: 7.55-
Week 0: 8.01-
Week 0: >=8.50-
Week 0: Missing0-
Week 12: 6.09-
Week 12: 6.514-
Week 12: 7.011-
Week 12: 7.57-
Week 12: 8.02-
Week 12: >=8.51-
Week 12: Missing1-
Semaglutide 0.8 mgWeek 0: 6.010-
Week 0: 6.513-
Week 0: 7.012-
Week 0: 7.55-
Week 0: 8.00-
Week 0: >=8.50-
Week 0: Missing1-
Week 12: 6.010-
Week 12: 6.57-
Week 12: 7.011-
Week 12: 7.53-
Week 12: 8.02-
Week 12: >=8.51-
Week 12: Missing3-
Semaglutide 0.8 mg (With Titration)Week 0: 6.011-
Week 0: 6.513-
Week 0: 7.08-
Week 0: 7.58-
Week 0: 8.00-
Week 0: >=8.51-
Week 0: Missing2-
Week 12: 6.08-
Week 12: 6.510-
Week 12: 7.015-
Week 12: 7.55-
Week 12: 8.01-
Week 12: >=8.51-
Week 12: Missing1-
Semaglutide 1.6 mg (With Titration)Week 0: 6.014-
Week 0: 6.510-
Week 0: 7.012-
Week 0: 7.57-
Week 0: 8.03-
Week 0: >=8.50-
Week 0: Missing1-
Week 12: 6.013-
Week 12: 6.511-
Week 12: 7.010-
Week 12: 7.55-
Week 12: 8.01-
Week 12: >=8.52-
Week 12: Missing1-
Liraglutide 1.2 mgWeek 0: 6.08-
Week 0: 6.516-
Week 0: 7.014-
Week 0: 7.53-
Week 0: 8.02-
Week 0: >=8.50-
Week 0: Missing2-
Week 12: 6.09-
Week 12: 6.513-
Week 12: 7.016-
Week 12: 7.54-
Week 12: 8.00-
Week 12: >=8.51-
Week 12: Missing0-
Liraglutide 1.8 mgWeek 0: 6.012-
Week 0: 6.511-
Week 0: 7.019-
Week 0: 7.52-
Week 0: 8.01-
Week 0: >=8.52-
Week 0: Missing3-
Week 12: 6.010-
Week 12: 6.514-
Week 12: 7.015-
Week 12: 7.53-
Week 12: 8.02-
Week 12: >=8.51-
Week 12: Missing2-
Secondary/registry result

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)

Time frame:Week 0, week 12

categorical status, descriptive

Posted result

GroupParticipants95% CI
PlaceboWeek 0: Negative45-
Week 0: 0.30-
Week 0: 1.00-
Week 0: Missing1-
Week 12: Negative40-
Week 12: Trace0-
Week 12: 0.34-
Week 12: 1.00-
Week 12: >=3.00-
Week 12: Missing0-
Semaglutide 0.1 mgWeek 0: Negative47-
Week 0: 0.30-
Week 0: 1.00-
Week 0: Missing0-
Week 12: Negative43-
Week 12: Trace0-
Week 12: 0.32-
Week 12: 1.00-
Week 12: >=3.00-
Week 12: Missing1-
Semaglutide 0.2 mgWeek 0: Negative41-
Week 0: 0.32-
Week 0: 1.00-
Week 0: Missing0-
Week 12: Negative35-
Week 12: Trace0-
Week 12: 0.33-
Week 12: 1.01-
Week 12: >=3.00-
Week 12: Missing2-
Semaglutide 0.4 mgWeek 0: Negative44-
Week 0: 0.34-
Week 0: 1.00-
Week 0: Missing0-
Week 12: Negative41-
Week 12: Trace0-
Week 12: 0.33-
Week 12: 1.00-
Week 12: >=3.00-
Week 12: Missing1-
Semaglutide 0.8 mgWeek 0: Negative39-
Week 0: 0.32-
Week 0: 1.00-
Week 0: Missing0-
Week 12: Negative31-
Week 12: Trace0-
Week 12: 0.33-
Week 12: 1.00-
Week 12: >=3.00-
Week 12: Missing3-
Semaglutide 0.8 mg (With Titration)Week 0: Negative40-
Week 0: 0.30-
Week 0: 1.01-
Week 0: Missing2-
Week 12: Negative36-
Week 12: Trace0-
Week 12: 0.33-
Week 12: 1.01-
Week 12: >=3.00-
Week 12: Missing1-
Semaglutide 1.6 mg (With Titration)Week 0: Negative46-
Week 0: 0.30-
Week 0: 1.00-
Week 0: Missing1-
Week 12: Negative39-
Week 12: Trace1-
Week 12: 0.32-
Week 12: 1.00-
Week 12: >=3.00-
Week 12: Missing1-
Liraglutide 1.2 mgWeek 0: Negative41-
Week 0: 0.32-
Week 0: 1.00-
Week 0: Missing2-
Week 12: Negative40-
Week 12: Trace0-
Week 12: 0.31-
Week 12: 1.01-
Week 12: >=3.01-
Week 12: Missing0-
Liraglutide 1.8 mgWeek 0: Negative45-
Week 0: 0.31-
Week 0: 1.01-
Week 0: Missing3-
Week 12: Negative41-
Week 12: Trace0-
Week 12: 0.33-
Week 12: 1.01-
Week 12: >=3.00-
Week 12: Missing2-
Secondary/registry result

Change From Baseline in Calcitonin

Time frame:Week 0, week 12.

Thyroid event

change from baseline, descriptive

Posted result

GroupMean · ng/L95% CI
Placebo0.43-
Semaglutide 0.1 mg0.48-
Semaglutide 0.2 mg-0.48-
Semaglutide 0.4 mg0.62-
Semaglutide 0.8 mg0.45-
Semaglutide 0.8 mg (With Titration)0.87-
Semaglutide 1.6 mg (With Titration)0.76-
Liraglutide 1.2 mg0.55-
Liraglutide 1.8 mg0.01-
Secondary/registry result

Percentage of Subjects Developing Anti-semaglutide Antibodies

Time frame:After 12 weeks of treatment

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupNumber · Percentage (%) of participants95% CI
Placebo0-
Semaglutide 0.1 mg0-
Semaglutide 0.2 mg0-
Semaglutide 0.4 mg0-
Semaglutide 0.8 mg0-
Semaglutide 0.8 mg (With Titration)0-
Semaglutide 1.6 mg (With Titration)3-
Secondary/protocol endpoint

Percentage of Subjects With an Adverse Events

Time frame:After 12 weeks of treatment.

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

Percentage of Subjects With Hypoglycaemic Episode

Time frame:After 12 weeks of treatment

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Change From Baseline in ECG

Time frame:Week 0, week 12.

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)

Time frame:Week 0, week 12

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)

Time frame:Week 0, week 12.

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)

Time frame:Week 0, week 12

descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)

Time frame:Week 0, week 12

descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)

Time frame:Week 0, week 12

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)

Time frame:Week 0, week 12

descriptive

Secondary/protocol endpoint

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)

Time frame:Week 0, week 12

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Calcitonin

Time frame:Week 0, week 12.

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Percentage of Subjects Developing Anti-semaglutide Antibodies

Time frame:After 12 weeks of treatment

Immunogenicity (ADA)

threshold achievement, event

Publications (1)

Bibliography

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

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.