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

NCT ID: NCT03693430

Last Updated: 2023-07-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2021-03-23

Brief Summary

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This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. 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 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Semaglutide

Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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

Placebo

Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Group Type PLACEBO_COMPARATOR

Placebo (Semaglutide)

Intervention Type DRUG

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

Interventions

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Semaglutide

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

Intervention Type DRUG

Placebo (Semaglutide)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, age more than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) more than or equal to 30 kg/m\^2 or more than or equal to 27 kg/m\^2 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

* HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Los Angeles, California, United States

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Novo Nordisk Investigational Site

Aurora, Colorado, United States

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Novo Nordisk Investigational Site

Golden, Colorado, United States

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Novo Nordisk Investigational Site

Waterbury, Connecticut, United States

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Jacksonville, Florida, United States

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Novo Nordisk Investigational Site

Ocala, Florida, United States

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Novo Nordisk Investigational Site

City of Saint Peters, Missouri, United States

Site Status

Novo Nordisk Investigational Site

Butte, Montana, United States

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Novo Nordisk Investigational Site

Albany, New York, United States

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Novo Nordisk Investigational Site

Rochester, New York, United States

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Novo Nordisk Investigational Site

Kingsport, Tennessee, United States

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Austin, Texas, United States

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Novo Nordisk Investigational Site

Round Rock, Texas, United States

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Novo Nordisk Investigational Site

Arlington, Virginia, United States

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Novo Nordisk Investigational Site

Surrey, British Columbia, Canada

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Novo Nordisk Investigational Site

Moncton, New Brunswick, Canada

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Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

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Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

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Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Novo Nordisk Investigational Site

Toronto, Ontario, Canada

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Novo Nordisk Investigational Site

Montreal, Quebec, Canada

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Novo Nordisk Investigational Site

Québec, , Canada

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Novo Nordisk Investigational Site

Budapest, , Hungary

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Novo Nordisk Investigational Site

Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Komárom, , Hungary

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Novo Nordisk Investigational Site

Szekszárd, , Hungary

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Novo Nordisk Investigational Site

Bologna, , Italy

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Novo Nordisk Investigational Site

Palermo, , Italy

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Novo Nordisk Investigational Site

Pisa, , Italy

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Novo Nordisk Investigational Site

Rome, , Italy

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Novo Nordisk Investigational Site

Siena, , Italy

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Novo Nordisk Investigational Site

Alcorcón, , Spain

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Novo Nordisk Investigational Site

Almería, , Spain

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Novo Nordisk Investigational Site

L'Hospitalet de Llobregat, , Spain

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Novo Nordisk Investigational Site

Pamplona, , Spain

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Novo Nordisk Investigational Site

Pozuelo de Alarcón, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Countries

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United States Canada Hungary Italy Spain

References

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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)

Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.

Reference Type BACKGROUND
PMID: 36655300 (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)

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)

Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.

Reference Type DERIVED
PMID: 36216945 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-003726-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1202-1740

Identifier Type: OTHER

Identifier Source: secondary_id

NN9536-4378

Identifier Type: -

Identifier Source: org_study_id

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