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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Short name STEP 2

NCTNCT03552757 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4374Other idU1111-1200-8148Other id2017-003414-10Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,210 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
13 countries

United States, Argentina, Canada, Germany, Greece, India, Japan, Puerto Rico, Russia, South Africa, Spain, United Arab Emirates, United Kingdom

Start
4 Jun 2018
Primary completion
24 Mar 2020
Completion
1 May 2020
First posted
12 Jun 2018
Last update posted
9 Nov 2021
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 3

    STEP 2

    NCT03552757

    4 Jun 2018 to 1 May 2020

Registry summary

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

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

Interventions

  • Semaglutide 1.0 mgDrug
  • Semaglutide 2.4 mgDrug
  • Placebo I (Semaglutide)Drug
  • Placebo II (Semaglutide)Drug

Arms3

  • Experimental

    Semaglutide 1.0 mg

    Participants will receive semaglutide 1.0 mg and semaglutide placebo I during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

  • Experimental

    Semaglutide 2.4 mg

    Participants will receive semaglutide 2.4 mg and semaglutide placebo II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

  • Placebo comparator

    Semaglutide placebo I/II

    Participants will receive semaglutide placebo I and II during 68-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2-week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

  2. Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 2 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Secondary outcomes(20)

  1. Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in body weight (%) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  2. Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥5% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  3. Change in Waist Circumference

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in waist circumference from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  4. Change in Body Weight (Kg)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in body weight (kg) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  5. Change in BMI

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in body mass index (BMI) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  6. Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥10% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  7. Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥15% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  8. Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥20% of their baseline body weight (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  9. Change in HbA1c (%)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in glycated haemoglobin (HbA1c (%)) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  10. Change in HbA1c (mmol/Mol)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in HbA1c (mmol/mol) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  11. Change in FPG (mg/dL)

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in fasting plasma glucose (FPG) from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  12. Change in Fasting Serum Insulin

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in fasting serum insulin from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  13. Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)

    Time frame · At week 68

    Registry description

    Number of participants who achieved HbA1c \<7% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  14. Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

    Time frame · At week 68

    Registry description

    Number of participants who achieved HbA1c ≤6.5% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  15. Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥10% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  16. Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%

    Time frame · At week 68

    Registry description

    Number of participants who achieved weight reduction ≥15% of their baseline body weight and HbA1c \<7.0% (yes/no) at week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  17. Change in Systolic Blood Pressure

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in systolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  18. Change in Diastolic Blood Pressure

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  19. Change in Total Cholesterol

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in total cholesterol (measured in milligram per decilitre (mg/dL)) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

  20. Change in HDL Cholesterol

    Time frame · Baseline (week 0) to week 68

    Registry description

    Change in high density lipoprotein (HDL; measured in mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. Results are based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact.

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) to week 68

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo

GroupValue (Percentage point of body weight)Spread
Semaglutide 2.4 mg-9.98.0
Placebo-3.35.5
Primary outcomeCount of participants· At week 68

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo

GroupValue (Participants)
Semaglutide 2.4 mg267
Placebo107
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

GroupValue (Percentage point of body weight)Spread
Semaglutide 2.4 mg-9.98.0
Semaglutide 1.0 mg-7.26.6
Secondary outcomeCount of participants· At week 68

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

GroupValue (Participants)
Semaglutide 2.4 mg267
Semaglutide 1.0 mg217
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Waist Circumference

GroupValue (Centimetre (cm))Spread
Semaglutide 1.0 mg-6.96.8
Semaglutide 2.4 mg-9.78.1
Placebo-4.36.5
Secondary outcomeMean· Baseline (week 0) to week 68

Change in Body Weight (Kg)

GroupValue (Kilogram (kg))Spread
Semaglutide 1.0 mg-7.16.7
Semaglutide 2.4 mg-9.98.5
Placebo-3.46.2
Secondary outcomeMean· Baseline (week 0) to week 68

Change in BMI

GroupValue (kilogram per square meter (kg/m^2))Spread
Semaglutide 1.0 mg-2.62.4
Semaglutide 2.4 mg-3.63.1
Placebo-1.22.1
Secondary outcomeCount of participants· At week 68

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%

GroupValue (Participants)
Semaglutide 1.0 mg109
Semaglutide 2.4 mg177
Placebo31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Semaglutide 1.0 mgParticipants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8 and 1.0 mg from week 9-68. Participants also received once-weekly placebo I (placebo matched to semaglutide 2.4 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.1 / 40231 / 402261 / 402
Semaglutide 2.4 mgParticipants received once-weekly s.c semaglutide injections for 68 weeks: 0.25 mg from week 1-4, 0.5 mg from week 5-8, 1.0 mg from week 9-12, 1.7 mg from week 13-16 and 2.4 mg from week 17-68. Participants also received once-weekly placebo II (placebo matched to semaglutide 1.0 mg) s.c. injection for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.1 / 40340 / 403284 / 403
PlaceboParticipants received once-weekly s.c placebo injections (both placebo I (placebo matched to semaglutide 1.0 mg) and placebo II (placebo matched to semaglutide 2.4 mg) for 68 weeks. Participants received the treatments as an adjunct to a reduced calorie diet and increased physical activity.1 / 40237 / 402190 / 402

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

Studies7

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2024

5 results

Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.

Wadden et al. 2024JAMA internal medicinecited by 77

PMID 39226070PMC11372653DOI 10.1001/jamainternmed.2024.4346PUB-39226070

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2021

6 results

Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.

Davies et al. 2021Lancet (London, England)cited by 1,104

PMID 33667417DOI 10.1016/s0140-6736(21)00213-0PUB-33667417

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2020

Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.

Kushner et al. 2020Obesity (Silver Spring, Md.)cited by 209

PMID 32441473PMC7318657DOI 10.1002/oby.22794PUB-32441473

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

Indexing hint: Randomized controlled trial · 2018

10 results

Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.

O'Neil et al. 2018Lancet (London, England)cited by 615

PMID 30122305DOI 10.1016/s0140-6736(18)31773-2PUB-30122305

Full text at the publisher10 results
Publisher pageSee results (10)

More studies

3 studies on this page

PubMed tag: none · 2025

Proteomic signatures reflect effects of semaglutide treatment for MASH.

Schattenberg et al. 2025JHEP reports : innovation in hepatologycited by 6

PMID 40980163PMC12447996DOI 10.1016/j.jhepr.2025.101521PUB-40980163

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2024

Corrected

Effect of semaglutide 2.4 mg on physical functioning and weight- and health-related quality of life in adults with overweight or obesity: Patient-reported outcomes from the STEP 1-4 trials.

Rubino et al. 2024Diabetes, obesity & metabolismcited by 38

PMID 38698650DOI 10.1111/dom.15620PUB-38698650

Full text at the publisher
Publisher pageRead the notice

PubMed tag: none · 2023

Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.

Heerspink et al. 2023Diabetes carecited by 74

PMID 36801984PMC10090901DOI 10.2337/dc22-1889PUB-36801984

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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 greater than or equal to 18 years at the time of signing informed consent * Body Mass Index (BMI) greater than or equal to 27 kg/m\^2 ' * History of at least one self-reported unsuccessful dietary effort to lose body weight * Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening Exclusion Criteria: * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m\^2 (less than 60 ml/min/1.73 m\^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

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