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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

Short name STEP 8

NCTNCT04074161 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4576Other idU1111-1233-0977
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
338 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
11 Sept 2019
Primary completion
27 Mar 2021
Completion
11 May 2021
First posted
29 Aug 2019
Last update posted
19 May 2023
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 3

    STEP 8

    NCT04074161

    11 Sept 2019 to 11 May 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will look at participants' body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, liraglutide or "dummy" medicine. Which treatment is decided by chance. Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week. Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study participants will have talks with study staff about eating healthy food and how to be more physically active. Participants will have 16 clinic visits and 7 phone calls with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug
  • LiraglutideDrug
  • Placebo (liraglutide)Drug

Arms4

  • Experimental

    Semaglutide

    Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity

  • Placebo comparator

    Placebo (semaglutide)

    Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity

  • Active comparator

    Liraglutide

    Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity

  • Placebo comparator

    Placebo (liraglutide)

    Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Secondary outcomes(20)

  1. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

    Time frame · From baseline (week 0) to week 68

    Registry description

    Number of participants who achieved \>= 10% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve \>= 10% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  2. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

    Time frame · From baseline (week 0) to week 68

    Registry description

    Number of participants who achieved \>= 15% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve \>= 15% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  3. Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

    Time frame · From baseline (week 0) to week 68

    Registry description

    Number of participants who achieved \>= 20% weight reduction from baseline (week 0) to week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved \>= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve \>= 20% weight reduction. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  4. Change From Baseline (Week 0) to Week 68 in Waist Circumference

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in waist circumference is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  5. Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in body weight is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  6. Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in body weight (%) is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  7. Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in systolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  8. Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in diastolic blood pressure is presented. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  9. Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  10. Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  11. Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  12. Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  13. Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  14. Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  15. Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  16. Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  17. Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  18. Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  19. Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

  20. Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)

    Time frame · Baseline (week 0), week 68

    Registry description

    Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline. Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), week 68

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)

GroupValue (Percentage of body weight)Spread
Semaglutide 2.4 mg-16.410.5
Liraglutide 3.0 mg-6.47.7
Secondary and other outcome results(7)
Secondary outcomeCount of participants· From baseline (week 0) to week 68

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg83
Liraglutide 3.0 mg30
Pooled Placebo12
Secondary outcomeCount of participants· From baseline (week 0) to week 68

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg65
Liraglutide 3.0 mg14
Pooled Placebo5
Secondary outcomeCount of participants· From baseline (week 0) to week 68

Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)

GroupValue (Participants)
Semaglutide 2.4 mg45
Liraglutide 3.0 mg7
Pooled Placebo2
Secondary outcomeMean· Baseline (week 0), week 68

Change From Baseline (Week 0) to Week 68 in Waist Circumference

GroupValue (centimeters (cm))Spread
Semaglutide 2.4 mg-13.610.0
Liraglutide 3.0 mg-6.88.4
Pooled Placebo-2.07.2
Secondary outcomeMean· Baseline (week 0), week 68

Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))

GroupValue (kilograms)Spread
Semaglutide 2.4 mg-15.810.2
Liraglutide 3.0 mg-6.89.5
Pooled Placebo-1.49.6
Secondary outcomeMean· Baseline (week 0), week 68

Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)

GroupValue (Percentage of body weight)Spread
Semaglutide 2.4 mg-16.410.5
Liraglutide 3.0 mg-6.47.7
Pooled Placebo-1.68.6
Secondary outcomeMean· Baseline (week 0), week 68

Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure

GroupValue (millimeters of mercury (mmHg))Spread
Semaglutide 2.4 mg-714
Liraglutide 3.0 mg-415
Pooled Placebo514

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 2.4 mgThe trial included an initial dose-escalation period during which the dose was gradually increased (0.24, 0.5, 1.0, 1.7 milligram (mg)) to the maintenance dose of semaglutide 2.4 mg once weekly (16-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). In week 44, all participants switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.0 / 12610 / 126115 / 126
Liraglutide 3.0 mgThe trial included an initial dose-escalation period during which the dose was gradually increased (0.6, 1.2, 1.8, 2.4 mg) to the maintenance dose of liraglutide 3.0 mg once daily (4-week dose-escalation period). After the dose escalation period, treatment continued on the maintenance dose up to week 68 (end of treatment). A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.0 / 12714 / 127115 / 127
Pooled PlaceboParticipants received placebo matched to either once weekly semaglutide or once daily liraglutide up to week 68 (end of treatment). In week 44, all participants randomized to semaglutide placebo switched from the PDS290 pen-injector to the DV3396 single-dose pen-injector. A follow-up visit (end of trial) for safety assessments was scheduled 7 weeks after end of treatment.0 / 856 / 8568 / 85

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

14 results

Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial.

Rubino et al. 2022JAMAcited by 749

PMID 35015037PMC8753508DOI 10.1001/jama.2021.23619PUB-35015037

Rights unknown14 results
Source linkSee results (14)

More studies

1 study on this page

Indexing hint: Clinical trial · 2022

Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial.

Snitker et al. 2022Diabetes, obesity & metabolismcited by 9

PMID 35791625PMC9805145DOI 10.1111/dom.14809PUB-35791625

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultWharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29. PMID 34775881

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age 18 years or older at the time of signing informed consent * Body mass index (BMI) equal to or above 30.0 kg/m\^2 or equal to or above 27.0 kg/m\^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease * History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion Criteria: * HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes mellitus * A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

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