A research study to see how semaglutide helps losing weight in people with excess weight (STEP UP).

Effect and safety of semaglutide 7.2 mg once-weekly in participants with obesity.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000790-94-NO

Enrollment

1400

Registered

2022-10-06

Start date

2023-01-03

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Wegovy 0.25 mg solution for injection in pre-filled pen Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Semaglutide CAS Number: 910463-68-2 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female. - Age above or equal to 18 years at the time of signing informed consent. - BMI above or equal to 30.0 kg/m^2. - History of at least one self-reported unsuccessful dietary effort to lose body weight. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: - HbA1c above or equal to 48 mmol/mol (6.5%) 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 above 5 kg (11 lbs) 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate the superiority of semaglutide s.c. 7.2 mg once-weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to relative change in body weight after 72 weeks, in adults with obesity. - To demonstrate the superiority of semaglutide s.c. 7.2 mg once-weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to achieving body weight reduction = 5% after 72 weeks, in adults with obesity.;Secondary Objective: In adults with obesity – for semaglutide s.c. 7.2 mg once-weekly as an adjunct to a reduced-calorie diet and increased physical activity: - To demonstrate the superiority a) versus placebo, - with respect to: - achieving body weight reduction = 10%, 15%, 20%, 25% respectively after 72 weeks - change in waist circumference after 72 weeks b) versus semaglutide s.c. 2.4 mg with respect to: - relative change in body weight after 72 weeks - achieving body weight reduction = 20%, 25% respectively after 72 weeks. - To compare the efficacy versus placebo on other factors related to body weight, body composition , Cardiovascular risk factors, Glucose metabolism after 72 weeks. - To compare the safety versus placebo with respect to pulse after 72 weeks - To compare the safety and tolerability after 81 weeks versus placebo and versus semaglutide s.c. 2.4 mg ;Primary end point(s): 1. Relative change in body weight 2. =5% body weight reduction (yes/no);Timepoint(s) of evaluation of this end point: 1-2. From baseline (week 0) to end of treatment (week 72)	—

Measure

Time frame

Main Objective: - To demonstrate the superiority of semaglutide s.c. 7.2 mg once-weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to relative change in body weight after 72 weeks, in adults with obesity. - To demonstrate the superiority of semaglutide s.c. 7.2 mg once-weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to achieving body weight reduction = 5% after 72 weeks, in adults with obesity.;Secondary Objective: In adults with obesity – for semaglutide s.c. 7.2 mg once-weekly as an adjunct to a reduced-calorie diet and increased physical activity: - To demonstrate the superiority a) versus placebo, - with respect to: - achieving body weight reduction = 10%, 15%, 20%, 25% respectively after 72 weeks - change in waist circumference after 72 weeks b) versus semaglutide s.c. 2.4 mg with respect to: - relative change in body weight after 72 weeks - achieving body weight reduction = 20%, 25% respectively after 72 weeks. - To compare the efficacy versus placebo on other factors related to body weight, body composition , Cardiovascular risk factors, Glucose metabolism after 72 weeks. - To compare the safety versus placebo with respect to pulse after 72 weeks - To compare the safety and tolerability after 81 weeks versus placebo and versus semaglutide s.c. 2.4 mg ;Primary end point(s): 1. Relative change in body weight 2. =5% body weight reduction (yes/no);Timepoint(s) of evaluation of this end point: 1-2. From baseline (week 0) to end of treatment (week 72)

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Secondary

Measure	Time frame
Secondary end point(s): 1. =10% body weight reduction (yes/no) 2. =15% body weight reduction (yes/no) 3. =20% body weight reduction (yes/no) 4. =25% body weight reduction (yes/no) 5. Change in waist circumference 6. Relative change in body weight 7. Change in body weight 8. Change in BMI 9. Change in total fat mass 10. Change in lean body mass 11. Change in visceral fat mass 12. Change in systolic blood pressure 13. Change in diastolic blood pressure 14. Change in total cholesterol 15. Change in high-density lipoprotein (HDL) cholesterol 16. Change in low-density lipoprotein (LDL) cholesterol 17. Change in very low-density lipoprotein (VLDL) cholesterol 18. Change in triglycerides 19. Change in free fatty acids 20. Change in high-sensitivity c reactive protein (hsCRP) 21. Change in lipid-lowering treatment (decrease, no change, increase) 22. Change in antihypertensive treatment (decrease, no change, increase) 23. Change in HbA1c 24. Change in fasting plasma glucose 25. Change in fasting serum insulin 26. Change in glycaemic category (Normo glycaemia, pre diabetes, T2D) 27. Number of Adverse Events (AEs) 28. Number of Serious Adverse Events (SAEs) 29. Change in pulse;Timepoint(s) of evaluation of this end point: 1-26. From baseline (week 0) to end of treatment (week 72) 27-28. From baseline (week 0) to end of study (week 81) 29. From baseline (week 0) to end of treatment (week 72)	—

Measure

Time frame

Secondary end point(s): 1. =10% body weight reduction (yes/no) 2. =15% body weight reduction (yes/no) 3. =20% body weight reduction (yes/no) 4. =25% body weight reduction (yes/no) 5. Change in waist circumference 6. Relative change in body weight 7. Change in body weight 8. Change in BMI 9. Change in total fat mass 10. Change in lean body mass 11. Change in visceral fat mass 12. Change in systolic blood pressure 13. Change in diastolic blood pressure 14. Change in total cholesterol 15. Change in high-density lipoprotein (HDL) cholesterol 16. Change in low-density lipoprotein (LDL) cholesterol 17. Change in very low-density lipoprotein (VLDL) cholesterol 18. Change in triglycerides 19. Change in free fatty acids 20. Change in high-sensitivity c reactive protein (hsCRP) 21. Change in lipid-lowering treatment (decrease, no change, increase) 22. Change in antihypertensive treatment (decrease, no change, increase) 23. Change in HbA1c 24. Change in fasting plasma glucose 25. Change in fasting serum insulin 26. Change in glycaemic category (Normo glycaemia, pre diabetes, T2D) 27. Number of Adverse Events (AEs) 28. Number of Serious Adverse Events (SAEs) 29. Change in pulse;Timepoint(s) of evaluation of this end point: 1-26. From baseline (week 0) to end of treatment (week 72) 27-28. From baseline (week 0) to end of study (week 81) 29. From baseline (week 0) to end of treatment (week 72)

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Countries

Bulgaria, Canada, European Union, Greece, Hungary, Norway, Portugal, Slovakia, South Africa, United States

Contacts

Public ContactClinical Transparency (2834)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026