OverweightPhase 3STEP 6NCT03811574
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 28 sites in 2 countries.
Trial summary
This study will look at the change in participants' 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 21 Jan 2019to 20 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age more than or equal to 18 years at the time of signing informed consent
- BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Who cannot join
- A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- For subjects with T2D at screening (Japan only): a) 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 co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
Japan22 sites
Novo Nordisk Investigational Site
Adachi-ku, Tokyo, 123-0845
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, 113-8655
Novo Nordisk Investigational Site
Chitose, Hokkaido, 066-0032
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, 103-0002
Novo Nordisk Investigational Site
Chuo-ku,Tokyo, 103-0025
Novo Nordisk Investigational Site
Gunma, 373-0036
Novo Nordisk Investigational Site
Ibaraki, 311-0113
Novo Nordisk Investigational Site
Kanagawa, 232-0064
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, 582-0005
Novo Nordisk Investigational Site
Kobe, Hyogo, 650-0017
Novo Nordisk Investigational Site
Kumamoto, 862-0976
Novo Nordisk Investigational Site
Miyazaki, 880-0034
Novo Nordisk Investigational Site
Sapporo-shi, Hokkaido, 004-0004
Novo Nordisk Investigational Site
Shimotsuke-shi, Tochigi, 329-0433
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
Novo Nordisk Investigational Site
Tokyo, 103-0027
Novo Nordisk Investigational Site
Tokyo, 103-0028
Novo Nordisk Investigational Site
Tokyo, 104-0031
Novo Nordisk Investigational Site
Tokyo, 125-0054
Novo Nordisk Investigational Site
Tokyo, 160-0008
Novo Nordisk Investigational Site
Toyama-shi, Toyama, 930-0194
Novo Nordisk Investigational Site
Yamato-shi, Kanagawa, 242-0004
South Korea6 sites
Novo Nordisk Investigational Site
Gyeonggi-do, 13620
Novo Nordisk Investigational Site
Seoul, 05505
Novo Nordisk Investigational Site
Seoul, 06273
Novo Nordisk Investigational Site
Seoul, 06351
Novo Nordisk Investigational Site
Seoul, 06591
Novo Nordisk Investigational Site
Yangsan, 626-770
About this study
Official title: Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity
This study will look at the change in participants' 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 medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide, Placebo (semaglutide)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
Placebo (semaglutide)Drug
Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 2.4 mg | Experimental | Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68. Receives: Drug: Semaglutide |
| Placebo (semaglutide 2.4 mg) | Placebo comparator | Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68. Receives: Drug: Placebo (semaglutide) |
| Semaglutide 1.7 mg | Experimental | Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68. Receives: Drug: Semaglutide |
| Placebo (semaglutide 1.7 mg) | Placebo comparator | Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68. Receives: Drug: Placebo (semaglutide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (%)
Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Measured: Baseline (week 0), week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Measured: At week 68
Secondary outcomes (37)
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
Measured: At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: At week 68
Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest
Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Body Weight (Kg)
Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Visceral Fat Area (VFA) (%)
Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)
Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in HbA1c (%)
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in HbA1c (mmol/Mol)
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Fasting Plasma Glucose
Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Fasting Serum Insulin-ratio to Baseline
Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Total Cholesterol-ratio to Baseline
Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in High-density Lipoproteins (HDL)-Ratio to Baseline
Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Low-density Lipoproteins (LDL)-Ratio to Baseline
Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline
Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Free Fatty Acids-ratio to Baseline
Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Triglycerides-ratio to Baseline
Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline
Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: Baseline (week 0) to week 68
Change in Short Form 36 v2.0 Acute (SF-36) Score
SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.
Measured: Baseline (week 0) to week 68
Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score
The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
Measured: Baseline (week 0) to week 68
Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
Measured: At week 68
Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score
The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.
Measured: At week 68
Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)
Number of participants who achieved HbA1c <7% (53 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than the 7% and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: At week 68
Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and "No" infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.
Measured: At week 68
Number of Treatment-emergent AEs
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. 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 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Measured: Week 0 to week 75
Number of Serious Adverse Events
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.
Measured: Week 0 to week 75
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes
Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.
Measured: Week 0 to week 75
Change in Pulse
Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
Measured: Baseline (week 0) to week 68
Change in Amylase: Ratio to Baseline
Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
Measured: Baseline (week 0) to week 68
Change in Lipase: Ratio to Baseline
Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
Measured: Baseline (week 0) to week 68
Change in Calcitonin: Ratio to Baseline
Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
Measured: Baseline (week 0) to week 68
Change in QTCF Interval
Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.
Measured: Baseline (week 0) to week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start21 Jan 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811574
- Sponsor's protocol ID
- NN9536-4382
- Other IDs
- U1111-1201-1629
- Acronym
- STEP 6
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2019
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. 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. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
PubMed 33667417Kadowaki T, Nishida T, Ogawa W, Overvad M, Tobe K, Yamauchi T. Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial. Obes Res Clin Pract. 2025 Mar-Apr;19(2):146-153. doi: 10.1016/j.orcp.2025.03.003. Epub 2025 Apr 4.
PubMed 40189961Kadowaki T, Isendahl J, Khalid U, Lee SY, Nishida T, Ogawa W, Tobe K, Yamauchi T, Lim S; STEP 6 investigators. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2022 Mar;10(3):193-206. doi: 10.1016/S2213-8587(22)00008-0. Epub 2022 Feb 4.
PubMed 35131037
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03811574
- Acronym / sponsor ID
- STEP 6 / NN9536-4382
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the change in participants' 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 medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 2.4 mg | Experimental | Drug: SemaglutideParticipants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68. |
| Placebo (semaglutide 2.4 mg) | Placebo comparator | Drug: Placebo (semaglutide)Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68. |
| Semaglutide 1.7 mg | Experimental | Drug: SemaglutideParticipants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68. |
| Placebo (semaglutide 1.7 mg) | Placebo comparator | Drug: Placebo (semaglutide)Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age more than or equal to 18 years at the time of signing informed consent
- BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Key exclusion criteria (3 listed)
- A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- For subjects with T2D at screening (Japan only): a) 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 co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. | Drug | Semaglutide 1.7 mg, Semaglutide 2.4 mg |
| Placebo (semaglutide)Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals. | Drug | Placebo (semaglutide 1.7 mg), Placebo (semaglutide 2.4 mg) |
Primary outcome
Change in Body Weight (%)
Time frame: Baseline (week 0), week 68
Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%
Time frame: At week 68
Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).
37 secondary outcomes
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%
Time frame: At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%
Time frame: At week 68
Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%
Time frame: At week 68
Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest
Time frame: Baseline (week 0) to week 68
Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline
Time frame: Baseline (week 0) to week 68
Change in Body Weight (Kg)
Time frame: Baseline (week 0) to week 68
Change in Body Mass Index (BMI)
Time frame: Baseline (week 0) to week 68
Change in Visceral Fat Area (VFA) (%)
Time frame: Baseline (week 0) to week 68
Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)
Time frame: Baseline (week 0) to week 68
Change in HbA1c (%)
Time frame: Baseline (week 0) to week 68
Change in HbA1c (mmol/Mol)
Time frame: Baseline (week 0) to week 68
Change in Fasting Plasma Glucose
Time frame: Baseline (week 0) to week 68
Change in Fasting Serum Insulin-ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Systolic Blood Pressure
Time frame: Baseline (week 0) to week 68
Change in Diastolic Blood Pressure
Time frame: Baseline (week 0) to week 68
Change in Total Cholesterol-ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in High-density Lipoproteins (HDL)-Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Low-density Lipoproteins (LDL)-Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Free Fatty Acids-ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Triglycerides-ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Short Form 36 v2.0 Acute (SF-36) Score
Time frame: Baseline (week 0) to week 68
Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score
Time frame: Baseline (week 0) to week 68
Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score
Time frame: At week 68
Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score
Time frame: At week 68
Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)
Time frame: At week 68
Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)
Time frame: At week 68
Number of Treatment-emergent AEs
Time frame: Week 0 to week 75
Number of Serious Adverse Events
Time frame: Week 0 to week 75
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes
Time frame: Week 0 to week 75
Change in Pulse
Time frame: Baseline (week 0) to week 68
Change in Amylase: Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Lipase: Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in Calcitonin: Ratio to Baseline
Time frame: Baseline (week 0) to week 68
Change in QTCF Interval
Time frame: Baseline (week 0) to week 68
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33667417Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. 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. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.
- Derived from this study: PubMed 40189961Kadowaki T, Nishida T, Ogawa W, Overvad M, Tobe K, Yamauchi T. Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial. Obes Res Clin Pract. 2025 Mar-Apr;19(2):146-153. doi: 10.1016/j.orcp.2025.03.003. Epub 2025 Apr 4.
- Derived from this study: PubMed 35131037Kadowaki T, Isendahl J, Khalid U, Lee SY, Nishida T, Ogawa W, Tobe K, Yamauchi T, Lim S; STEP 6 investigators. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2022 Mar;10(3):193-206. doi: 10.1016/S2213-8587(22)00008-0. Epub 2022 Feb 4.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (%) (time frame: Baseline (week 0), week 68). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.