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

NCT05646706
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Completed
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Participants
1,407
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Lead sponsor
Novo Nordisk A/S
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Start date
2023-01-04
clinicaltrials.gov
Number of sites
107
clinicaltrials.gov

Summary
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.
clinicaltrials.gov
Acronym
STEP UP
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Short title
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
clinicaltrials.gov
Official title
Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2024-11-26
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First posted
2022-12-12
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Registry last updated
2026-04-23
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Primary completion date
2024-10-30
clinicaltrials.gov
Start date
2023-01-04
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Actual participants
1,407
clinicaltrials.gov
Participants
1,407
clinicaltrials.gov
Participant count basis
Actual
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Protocol amendments
2
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Number of sites
107
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05646706
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05646706
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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)

    Timeframe: 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%.

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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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 (%)

    Timeframe: 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)

    Timeframe: 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 (%)

    Timeframe: 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)

    Timeframe: 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 (%)

    Timeframe: 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)

    Timeframe: 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 (%)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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).

And 19 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Univ of Alabama BirminghamBirmingham, United States
  • Chambliss Clinical Trials, LLCMontgomery, United States
  • Healthscan Clinical Trials,LLC.Montgomery, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Jacksonville Ctr For Clin ResJacksonville, United States
  • Florida Inst For Clin Res LLCOrlando, United States
  • Florida Institute For Clinical Research LLCOrlando, United States
  • East West Med Res InstHonolulu, United States
  • Midwest Inst For Clin ResIndianapolis, United States
  • AMC Community EndocrinologyAlbany, United States
  • University of North CarolinaChapel Hill, United States
  • PharmQuest Life Sciences LLCGreensboro, United States
  • Medical University Of South CarolinaCharleston, United States
  • Amarillo Med Spec LLPAmarillo, United States
  • Elligo Clin Res CentreAustin, United States
  • Velocity Clin Res, DallasDallas, United States
  • UT Southwestern Medical Center-CRUDallas, United States
  • DCOL Ctr for Clin ResLongview, United States
  • Sugar Lakes Family Practice PASugar Land, United States
  • National Clin Res Inc.Richmond, United States
  • Selma Medical AssociatesWinchester, United States
  • Medical centre Zdrave 1 OODKozloduy, Bulgaria
  • Medical center Hippocrates Lukovit EOODLukovit, Bulgaria
  • Petrich, Bulgaria
  • Medical center Smolyan clinical research OODSmolyan, Bulgaria

And 82 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2022-000790-94
  • U1111-1274-4259
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)