MedDataX Logo

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT ID: NCT03548987

Last Updated: 2022-01-19

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

902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2020-03-20

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 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 medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.

The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT03548935

Metabolism and Nutrition Disorder Overweight or Obesity
COMPLETED PHASE3

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

NCT03552757

Obesity Overweight
COMPLETED PHASE3

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

NCT03693430

Overweight Obesity
COMPLETED PHASE3

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

NCT05040971

Obesity
COMPLETED PHASE3

A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

NCT06041217

Overweight Obesity
COMPLETED PHASE3

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.

Metabolism and Nutrition Disorder Obesity

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
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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

Semaglutide

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68).

The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Subcutaneous (under the skin) injection of semaglutide once-weekly.

Placebo

Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.

Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).

The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.

Group Type PLACEBO_COMPARATOR

Semaglutide

Intervention Type DRUG

Subcutaneous (under the skin) injection of semaglutide once-weekly.

Placebo

Intervention Type DRUG

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.

Interventions

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

Semaglutide

Subcutaneous (under the skin) injection of semaglutide once-weekly.

Intervention Type DRUG

Placebo

Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.

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 greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm with the presence of at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
* History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria

* Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central laboratory at screening
* A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
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

Anniston, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

San Diego, California, United States

Site Status

Novo Nordisk Investigational Site

Alpharetta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Suwanee, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Louisville, Kentucky, United States

Site Status

Novo Nordisk Investigational Site

Baton Rouge, Louisiana, United States

Site Status

Novo Nordisk Investigational Site

Elkridge, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Buckley, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Site Status

Novo Nordisk Investigational Site

New York, New York, 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

Raleigh, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Salisbury, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Dayton, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Bristol, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Bristol, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Chattanooga, 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

Arlington, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Richmond, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Wenatchee, Washington, United States

Site Status

Novo Nordisk Investigational Site

Frederiksberg C, , Denmark

Site Status

Novo Nordisk Investigational Site

Køge, , Denmark

Site Status

Novo Nordisk Investigational Site

Haifa, , Israel

Site Status

Novo Nordisk Investigational Site

Jerusalem, , Israel

Site Status

Novo Nordisk Investigational Site

Kfar Saba, , Israel

Site Status

Novo Nordisk Investigational Site

Petah Tikva, , Israel

Site Status

Novo Nordisk Investigational Site

Tel Aviv, , Israel

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Amsterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Amsterdam, , Netherlands

Site Status

Novo Nordisk Investigational Site

Arnhem, , Netherlands

Site Status

Novo Nordisk Investigational Site

Braga, , Portugal

Site Status

Novo Nordisk Investigational Site

Coimbra, , Portugal

Site Status

Novo Nordisk Investigational Site

Matosinhos Municipality, , Portugal

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

Porto, , Portugal

Site Status

Novo Nordisk Investigational Site

Vila Nova de Gaia, , Portugal

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

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Sabadell, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Uppsala, , Sweden

Site Status

Novo Nordisk Investigational Site

Geneva, , Switzerland

Site Status

Novo Nordisk Investigational Site

Olten, , Switzerland

Site Status

Novo Nordisk Investigational Site

Sankt Gallen, , Switzerland

Site Status

Novo Nordisk Investigational Site

Sankt Gallen, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zollikerberg, , Switzerland

Site Status

Novo Nordisk Investigational Site

Zurich, , Switzerland

Site Status

Novo Nordisk Investigational Site

Kharkiv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Kyiv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Kyiv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Kyiv, , Ukraine

Site Status

Novo Nordisk Investigational Site

Odesa, , Ukraine

Site Status

Countries

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

United States Denmark Israel Netherlands Portugal South Africa Spain Sweden Switzerland Ukraine

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)

Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D; STEP 4 Investigators. Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity: The STEP 4 Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1414-1425. doi: 10.1001/jama.2021.3224.

Reference Type RESULT
PMID: 33755728 (View on PubMed)

Wilkinson L, Holst-Hansen T, Laursen PN, Rinnov AR, Batterham RL, Garvey WT. Effect of semaglutide 2.4 mg once weekly on 10-year type 2 diabetes risk in adults with overweight or obesity. Obesity (Silver Spring). 2023 Sep;31(9):2249-2259. doi: 10.1002/oby.23842.

Reference Type DERIVED
PMID: 37605636 (View on PubMed)

Kosiborod MN, Bhatta M, Davies M, Deanfield JE, Garvey WT, Khalid U, Kushner R, Rubino DM, Zeuthen N, Verma S. Semaglutide improves cardiometabolic risk factors in adults with overweight or obesity: STEP 1 and 4 exploratory analyses. Diabetes Obes Metab. 2023 Feb;25(2):468-478. doi: 10.1111/dom.14890. Epub 2022 Oct 28.

Reference Type DERIVED
PMID: 36200477 (View on PubMed)

Perreault L, Davies M, Frias JP, Laursen PN, Lingvay I, Machineni S, Varbo A, Wilding JPH, Wallenstein SOR, le Roux CW. Changes in Glucose Metabolism and Glycemic Status With Once-Weekly Subcutaneous Semaglutide 2.4 mg Among Participants With Prediabetes in the STEP Program. Diabetes Care. 2022 Oct 1;45(10):2396-2405. doi: 10.2337/dc21-1785.

Reference Type DERIVED
PMID: 35724304 (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.

U1111-1201-0898

Identifier Type: OTHER

Identifier Source: secondary_id

2017-003473-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9536-4376

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.
NCT04251156 COMPLETED PHASE3
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range
NCT05564117 COMPLETED PHASE3
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
NCT02453711 COMPLETED PHASE2
Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity
NCT04074161 COMPLETED PHASE3
STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity
NCT03811574 COMPLETED PHASE3
Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
NCT05035095 COMPLETED PHASE3
Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects
NCT05548647 COMPLETED PHASE4
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
NCT03611582 COMPLETED PHASE3
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity
NCT03574597 COMPLETED PHASE3
Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
NCT05064735 COMPLETED PHASE3
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
NCT03600480 COMPLETED PHASE1
A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes
NCT04109547 COMPLETED PHASE3
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
NCT03574584 COMPLETED PHASE1
A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
NCT05236517 COMPLETED PHASE1
A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity
NCT03842202 COMPLETED PHASE1
A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
NCT04102189 COMPLETED PHASE3
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
NCT05486065 COMPLETED PHASE2
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
NCT05646706 COMPLETED PHASE3
A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
NCT05649137 COMPLETED PHASE3
Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
NCT04916470 COMPLETED PHASE3
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
NCT04969939 COMPLETED PHASE2
Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity
NCT04998136 COMPLETED PHASE3
Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
NCT03856047 COMPLETED PHASE2
A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese
NCT03707990 COMPLETED PHASE1
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)
NCT05890976 COMPLETED PHASE3