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STEP UP

CompletedPhase 3Results posted

A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

107

Recruiting sites

Enrollment

1,407

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, % change≥5% weight-loss responders

Footprint

Where this trial recruits

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

Identifiers

Registered as

NCT IDNCT05646706
Org study IDNN9536-4999
Secondary ID2022-000790-94
Secondary IDU1111-1274-4259World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-12-12actual
Study start2023-01-04actual
Primary completion2024-10-30actual
Study completion2024-11-26actual
Last update posted2026-04-23actual
Results first posted2026-04-23actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Male or female.
Age above or equal to 18 years at the time of signing informed consent.
Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2).
History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening.
History of type 1 or type 2 diabetes.
Treatment with glucose-lowering agent(s) within 90 days before screening.
A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records.
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Endpoints (92)

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

Weight & body composition
42
Cardiometabolic biomarkers
32
Glycemic / diabetes
10
Safety / tolerability / PK
8

Weight & body composition

42 endpoints
Primary/registry result

Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage (%) change in body weight95% CI
Semaglutide 7.2 mg-19.5
Placebo-3.8
Treatment difference-14.8195% CI-16.21-13.41p<0.0001ANCOVA
Primary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

Time frame:At week 72

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes862
No88
PlaceboYes63
No108
Odds Ratio (OR)12.1095% CI8.3217.61p<0.0001Binary regression model
Primary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)

Time frame:At week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)

Time frame:At week 72

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes783
No167
PlaceboYes35
No136
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)

Time frame:At week 72

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes632
No318
PlaceboYes13
No158
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)

Time frame:At week 72

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes453
No497
PlaceboYes5
No166
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)

Time frame:At week 72

≥25% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes296
No654
PlaceboYes0
No171
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference

Time frame:Baseline (week 0), End of treatment (week 72)

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), Centimeter (cm)95% CI
Semaglutide 7.2 mg-18.0
Placebo-5.6
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage (%) change in body weight95% CI
Semaglutide 7.2 mg-19.5
Semaglutide 2.4 mg-16.4
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)

Time frame:At week 72

≥20% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes453
No497
Semaglutide 2.4 mgYes63
No126
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)

Time frame:At week 72

≥25% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgYes296
No654
Semaglutide 2.4 mgYes29
No160
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms (kg)95% CI
Semaglutide 7.2 mg-21.7
Placebo-4.3
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)

Time frame:Baseline (week 0), End of treatment (week 72)

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kilogram per square meter (kg/m^2)95% CI
Semaglutide 7.2 mg-7.7
Placebo-1.5
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kg95% CI
Semaglutide 7.2 mg-21.7
Semaglutide 2.4 mg-18.7
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Total fat mass

percent change from baseline, improvement

Posted result

GroupValue (mean), % of total fat volume95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-26.9
Placebo-2.7
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Total fat mass

change from baseline, improvement

Posted result

GroupValue (mean), liters95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-11.7
Placebo-1.5
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Lean mass

percent change from baseline, improvement

Posted result

GroupValue (mean), % of lean body volume95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-7.5
Placebo-0.4
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Lean mass

change from baseline, improvement

Posted result

GroupValue (mean), liters95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-1.9
Placebo-0.2
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Visceral fat, change

percent change from baseline, improvement

Posted result

GroupValue (mean), % of visceral fat volume95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-33.6
Placebo-8.8
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Visceral fat, change

change from baseline, improvement

Posted result

GroupValue (mean), liters95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-1.8
Placebo-0.2
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Body Weight (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), % of body weight95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-18.4
Placebo-2.1
Secondary/registry result

Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kg95% CI
Pooled Semaglutide (7.2 mg + 2.4 mg)-20.6
Placebo-2.7
Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no)

Time frame:At week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no)

Time frame:At week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)

Time frame:At week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)

Time frame:At week 72

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference

Time frame:Baseline (week 0), End of treatment (week 72)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no)

Time frame:At week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no)

Time frame:At week 72

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI)

Time frame:Baseline (week 0), End of treatment (week 72)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters)

Time frame:Baseline (week 0), End of treatment (week 72)

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Body Weight (%)

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg)

Time frame:Baseline (week 0), End of treatment (week 72)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), End of treatment (week 72)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), % of HbA1c95% CI
Semaglutide 7.2 mg-0.3
Placebo0.0
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose

Time frame:Baseline (week 0), End of treatment (week 72)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Semaglutide 7.2 mg-11.7
Placebo-1.7
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of fasting serum insulin95% CI
Semaglutide 7.2 mg0.61
Placebo0.90
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of fasting serum insulin95% CI
Semaglutide 7.2 mg0.61
Placebo0.90
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)

Time frame:Baseline (week 0), end of treatment (week 72)

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgNormo-glycaemia (week 0)574
Normo-glycaemia (week 0)21
Normo-glycaemia (week 0)0
Pre-diabetes (week 0)297
Pre-diabetes (week 0)59
Pre-diabetes (week 0)0
PlaceboNormo-glycaemia (week 0)75
Normo-glycaemia (week 0)20
Normo-glycaemia (week 0)2
Pre-diabetes (week 0)26
Pre-diabetes (week 0)42
Pre-diabetes (week 0)3
Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), End of treatment (week 72)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose

Time frame:Baseline (week 0), End of treatment (week 72)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

ratio, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

ratio, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes)

Time frame:Baseline (week 0), end of treatment (week 72)

HbA1c <5.7% achievement

categorical status, improvement

LOINC 4548-4

Cardiometabolic biomarkers

32 endpoints
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure

Time frame:Baseline (week 0), End of treatment (week 72)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), millimeters of mercury (mmHg)95% CI
Semaglutide 7.2 mg-10
Placebo-4
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure

Time frame:Baseline (week 0), End of treatment (week 72)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), mmHg95% CI
Semaglutide 7.2 mg-5
Placebo-1
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

GroupValue (geometric_mean), Ratio of total cholesterol95% CI
Semaglutide 7.2 mg0.94
Placebo1.00
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

GroupValue (geometric_mean), Ratio of total cholesterol95% CI
Semaglutide 7.2 mg0.94
Placebo1.00
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

GroupValue (geometric_mean), Ratio of HDL cholesterol95% CI
Semaglutide 7.2 mg1.08
Placebo1.02
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

GroupValue (geometric_mean), Ratio of HDL cholesterol95% CI
Semaglutide 7.2 mg1.08
Placebo1.02
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

GroupValue (geometric_mean), Ratio of LDL cholesterol95% CI
Semaglutide 7.2 mg0.92
Placebo0.98
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

GroupValue (geometric_mean), Ratio of LDL cholesterol95% CI
Semaglutide 7.2 mg0.92
Placebo0.98
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

VLDL, change

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of VLDL cholesterol95% CI
Semaglutide 7.2 mg0.76
Placebo1.00
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

VLDL, change

ratio, improvement

Posted result

GroupValue (geometric_mean), Ratio of VLDL cholesterol95% CI
Semaglutide 7.2 mg0.76
Placebo1.00
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio of triglycerides95% CI
Semaglutide 7.2 mg0.76
Placebo0.99
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupValue (geometric_mean), Ratio of triglycerides95% CI
Semaglutide 7.2 mg0.76
Placebo0.99
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

GroupValue (geometric_mean), Ratio of hsCRP95% CI
Semaglutide 7.2 mg0.38
Placebo0.89
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)

Time frame:At week 72

categorical status, descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgDecreased8
No change138
Increased17
PlaceboDecreased0
No change22
Increased6
Secondary/registry result/low confidence

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)

Time frame:At week 72

categorical status, descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Semaglutide 7.2 mgDecreased57
No change233
Increased32
PlaceboDecreased6
No change47
Increased6
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Change in Pulse

Time frame:Baseline (week 0), End of treatment (week 72)

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), Beats per minute (bpm)95% CI
Semaglutide 7.2 mg1
Placebo-2
Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure

Time frame:Baseline (week 0), End of treatment (week 72)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure

Time frame:Baseline (week 0), End of treatment (week 72)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL)- Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L)- Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline

Time frame:Baseline (week 0), End of treatment (week 72)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase)

Time frame:At week 72

categorical status, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase)

Time frame:At week 72

categorical status, improvement

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Change in Pulse

Time frame:Baseline (week 0), End of treatment (week 72)

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

8 endpoints
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)

Time frame:From baseline (week 0) to end of study (week 81)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 7.2 mg6430
Placebo743
Secondary/registry result

Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 0) to end of study (week 81)

Serious AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 7.2 mg100
Placebo16
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs

Time frame:From baseline (week 0) to end of study (week 81)

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 7.2 mg6430
Semaglutide 2.4 mg1133
Secondary/registry result

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs

Time frame:From baseline (week 0) to end of study (week 81)

Serious AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Semaglutide 7.2 mg100
Semaglutide 2.4 mg31
Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)

Time frame:From baseline (week 0) to end of study (week 81)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 0) to end of study (week 81)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs

Time frame:From baseline (week 0) to end of study (week 81)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs

Time frame:From baseline (week 0) to end of study (week 81)

Serious AEs (any)

event count, 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 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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