STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

NCT ID: NCT03811574

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2020-11-20

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Semaglutide 2.4 mg

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.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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 2.4 mg)

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.

Group Type: PLACEBO_COMPARATOR

Placebo (semaglutide)

Intervention Type: 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.

Semaglutide 1.7 mg

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.

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

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 1.7 mg)

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.

Group Type: PLACEBO_COMPARATOR

Placebo (semaglutide)

Intervention Type: 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.

Interventions

Semaglutide

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Adachi-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Bunkyo-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Chitose, Hokkaido, , Japan

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Novo Nordisk Investigational Site

Chuo-ku,Tokyo, , Japan

Novo Nordisk Investigational Site

Gunma, , Japan

Novo Nordisk Investigational Site

Ibaraki, , Japan

Novo Nordisk Investigational Site

Kanagawa, , Japan

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Kobe, Hyogo, , Japan

Novo Nordisk Investigational Site

Kumamoto, , Japan

Novo Nordisk Investigational Site

Miyazaki, , Japan

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Novo Nordisk Investigational Site

Shimotsuke-shi, Tochigi, , Japan

Novo Nordisk Investigational Site

Suita-shi, Osaka, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Tokyo, , Japan

Novo Nordisk Investigational Site

Toyama-shi, Toyama, , Japan

Novo Nordisk Investigational Site

Yamato-shi, Kanagawa, , Japan

Novo Nordisk Investigational Site

Gyeonggi-do, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

Novo Nordisk Investigational Site

Yangsan, , South Korea

Countries

Japan; South Korea

References

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.

Reference Type: RESULT

PMID: 33667417 (View on PubMed)

Kadowaki 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.

Reference Type: DERIVED

PMID: 40189961 (View on PubMed)

Kadowaki 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.

Reference Type: DERIVED

PMID: 35131037 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1201-1629

Identifier Type: OTHER

Identifier Source: secondary_id

NN9536-4382

Identifier Type: -

Identifier Source: org_study_id