MedDataX Logo

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

NCT ID: NCT03552757

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2020-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Overweight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Semaglutide 1.0 mg

Intervention Type DRUG

Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Placebo I (Semaglutide)

Intervention Type DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

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.

Group Type EXPERIMENTAL

Semaglutide 2.4 mg

Intervention Type DRUG

Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Placebo II (Semaglutide)

Intervention Type DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

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.

Group Type PLACEBO_COMPARATOR

Placebo I (Semaglutide)

Intervention Type DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Placebo II (Semaglutide)

Intervention Type DRUG

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semaglutide 1.0 mg

Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Intervention Type DRUG

Semaglutide 2.4 mg

Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Intervention Type DRUG

Placebo I (Semaglutide)

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.

Intervention Type DRUG

Placebo II (Semaglutide)

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Buena Park, California, United States

Site Status

Novo Nordisk Investigational Site

Concord, California, United States

Site Status

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

Lomita, California, United States

Site Status

Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

Mission Hills, California, United States

Site Status

Novo Nordisk Investigational Site

Spring Valley, California, United States

Site Status

Novo Nordisk Investigational Site

Tarzana, California, United States

Site Status

Novo Nordisk Investigational Site

Golden, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Clearwater, Florida, United States

Site Status

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Site Status

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Site Status

Novo Nordisk Investigational Site

Kissimmee, Florida, United States

Site Status

Novo Nordisk Investigational Site

St. Petersburg, Florida, United States

Site Status

Novo Nordisk Investigational Site

Tampa, Florida, United States

Site Status

Novo Nordisk Investigational Site

Alpharetta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Springfield, Illinois, United States

Site Status

Novo Nordisk Investigational Site

West Des Moines, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Topeka, Kansas, United States

Site Status

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Louisville, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

Olive Branch, Mississippi, United States

Site Status

Novo Nordisk Investigational Site

Butte, Montana, United States

Site Status

Novo Nordisk Investigational Site

Lawrenceville, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Greensboro, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Greenville, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Hickory, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Salisbury, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Wilmington, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Wadsworth, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Anderson, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Mt. Pleasant, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Bristol, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Austin, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Shavano Park, Texas, United States

Site Status

Novo Nordisk Investigational Site

St. George, Utah, United States

Site Status

Novo Nordisk Investigational Site

Winchester, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Olympia, Washington, United States

Site Status

Novo Nordisk Investigational Site

CABA, , Argentina

Site Status

Novo Nordisk Investigational Site

Chacabuco, , Argentina

Site Status

Novo Nordisk Investigational Site

Córdoba, , Argentina

Site Status

Novo Nordisk Investigational Site

Mendoza, , Argentina

Site Status

Novo Nordisk Investigational Site

Santiago del Estero, , Argentina

Site Status

Novo Nordisk Investigational Site

Calgary, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

Novo Nordisk Investigational Site

Concord, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

London, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Stoney Creek, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Saint-Marc-des-Carrieres, Quebec, Canada

Site Status

Novo Nordisk Investigational Site

Essen, , Germany

Site Status

Novo Nordisk Investigational Site

Falkensee, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Hamburg, , Germany

Site Status

Novo Nordisk Investigational Site

Lingen, , Germany

Site Status

Novo Nordisk Investigational Site

Münster, , Germany

Site Status

Novo Nordisk Investigational Site

Rehlingen-Siersburg, , Germany

Site Status

Novo Nordisk Investigational Site

Schweinfurt, , Germany

Site Status

Novo Nordisk Investigational Site

Stuttgart, , Germany

Site Status

Novo Nordisk Investigational Site

Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Haidari-Athens, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Ahmedabad, Gujarat, India

Site Status

Novo Nordisk Investigational Site

Bangalore, Karnataka, India

Site Status

Novo Nordisk Investigational Site

Kochi, Kerala, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Pune, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

New Dehli, New Delhi, India

Site Status

Novo Nordisk Investigational Site

Jaipur, Rajasthan, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Coimbatore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

Kolkata, West Bengal, India

Site Status

Novo Nordisk Investigational Site

New Delhi, , India

Site Status

Novo Nordisk Investigational Site

Secunderabad, , India

Site Status

Novo Nordisk Investigational Site

Chiba-shi, Chiba, , Japan

Site Status

Novo Nordisk Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka-shi, Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Ibaraki, , Japan

Site Status

Novo Nordisk Investigational Site

Kashiwara-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Mitaka-shi, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Sapporo-shi, Hokkaido, , Japan

Site Status

Novo Nordisk Investigational Site

Tochigi, , Japan

Site Status

Novo Nordisk Investigational Site

San Juan, , Puerto Rico

Site Status

Novo Nordisk Investigational Site

Barnaul, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Moscow, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Saint Petersburg, , Russia

Site Status

Novo Nordisk Investigational Site

Tomsk, , Russia

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Brits, North West, South Africa

Site Status

Novo Nordisk Investigational Site

Almería, , Spain

Site Status

Novo Nordisk Investigational Site

Córdoba, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Málaga, , Spain

Site Status

Novo Nordisk Investigational Site

San Cristóbal de La Laguna, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Valladolid, , Spain

Site Status

Novo Nordisk Investigational Site

Dubai, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Dubai, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Dubai, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Hatta, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Umm Al Quwain City, , United Arab Emirates

Site Status

Novo Nordisk Investigational Site

Chester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Crewe, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Glasgow, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Harrogate, North Yorkshire, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leicester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Middlesbrough, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Soham, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Stevenage, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Watford, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Wellingborough, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

References

Explore related publications, articles, or registry entries linked to this study.

Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.

Reference Type BACKGROUND
PMID: 32441473 (View on PubMed)

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)

Schattenberg JM, Gronbaek H, Kliers I, Ladelund S, Long MT, Nygard SB, Sanyal AJ, Davies MJ. Proteomic signatures reflect effects of semaglutide treatment for MASH. JHEP Rep. 2025 Jul 22;7(10):101521. doi: 10.1016/j.jhepr.2025.101521. eCollection 2025 Oct.

Reference Type DERIVED
PMID: 40980163 (View on PubMed)

Wadden TA, Brown GK, Egebjerg C, Frenkel O, Goldman B, Kushner RF, McGowan B, Overvad M, Fink-Jensen A. 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. JAMA Intern Med. 2024 Nov 1;184(11):1290-1300. doi: 10.1001/jamainternmed.2024.4346.

Reference Type DERIVED
PMID: 39226070 (View on PubMed)

Heerspink HJL, Apperloo E, Davies M, Dicker D, Kandler K, Rosenstock J, Sorrig R, Lawson J, Zeuthen N, Cherney D. 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. Diabetes Care. 2023 Apr 1;46(4):801-810. doi: 10.2337/dc22-1889.

Reference Type DERIVED
PMID: 36801984 (View on PubMed)

O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. 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. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

Reference Type DERIVED
PMID: 30122305 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1200-8148

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003414-10

Identifier Type: OTHER

Identifier Source: secondary_id

NN9536-4374

Identifier Type: -

Identifier Source: org_study_id