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OpenTrials
Completed

NCT Number: NCT05646706

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

This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical centre Zdrave 1 OOD, Kozloduy, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Placebo

Drug

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Primary outcomes

  1. Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight

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

    Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

  2. 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

    Number of participants who achieve body weight reduction >=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=5% and "no" defines participants who did not achieve body weight reduction >=5%.

Secondary outcomes

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

    Time frame: At week 72

    Number of participants who achieve body weight reduction >=10% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=10% and "no" defines participants who did not achieve body weight reduction >=10%.

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

    Time frame: At week 72

    Number of participants who achieve body weight reduction >=15% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=15% and "no" defines participants who did not achieve body weight reduction >=15%.

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

    Time frame: At week 72

    Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%.

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

    Time frame: At week 72

    Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%.

  5. Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference

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

    Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

  7. 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

    Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%.

  8. 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

    Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%.

  9. Semaglutide 7.2 mg Versus Placebo: Change in Body Weight

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

    Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in BMI from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in body weight from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented.

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

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

    Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented.

  20. Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure

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

    Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.

  21. Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure

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

    Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented.

  22. 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)

    Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  23. 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)

    Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  24. 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)

    Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  25. 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)

    Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  26. 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)

    Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  27. 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)

    Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  28. 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)

    Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  29. 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)

    Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

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

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

    Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

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

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

    Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  32. 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)

    Change in hsCRP (milligram per liter [mg/L]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

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

    Time frame: At week 72

    Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase.

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

    Time frame: At week 72

    Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase.

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

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

    Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented.

  36. Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose

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

    Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented.

  37. 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)

    Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  38. 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)

    Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0).

  39. 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)

    Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5%

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

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

    Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.

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

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

    Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.

  42. Semaglutide 7.2 mg Versus Placebo: Change in Pulse

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

    Change in pulse from baseline (week 0) to end of treatment (week 72) is presented.

  43. Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs

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

    Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP.

  44. Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs

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

    Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: STEP UP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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