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Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

NCT ID: NCT03856047

Last Updated: 2024-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

706 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-03-25

Brief Summary

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This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as 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 take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. 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 8 months. Participants will have 12 clinic visits 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

This is a twelve-armed trial comprising of five (0.3, 0.6, 1.2, 2.4 and 4.5 mg OW) of NNC0174-0833 arms and liraglutide 3.0 mg OD arm as active treatment arms and the corresponding 6 placebo arms as comparators. Participants will be randomised 6:1 between the active treatment arms and the placebo arms. The five different NNC0174-0833 placebo arms and the one liraglutide placebo arm will be pooled into one placebo group for statistical analyses of the results.
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

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NNC0174-0833, 4.5 mg

Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type EXPERIMENTAL

NNC0174-0833

Intervention Type DRUG

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

NNC0174-0833, 2.4 mg

Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type EXPERIMENTAL

NNC0174-0833

Intervention Type DRUG

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

NNC0174-0833, 1.2 mg

Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type EXPERIMENTAL

NNC0174-0833

Intervention Type DRUG

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

NNC0174-0833, 0.6 mg

Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type EXPERIMENTAL

NNC0174-0833

Intervention Type DRUG

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

NNC0174-0833 0.3 mg

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type EXPERIMENTAL

NNC0174-0833

Intervention Type DRUG

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo 2.4 mg (NNC0174-0833)

Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type DRUG

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo 4.5 mg (NNC0174-0833)

Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type DRUG

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo 1.2 mg (NNC0174-0833)

Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type DRUG

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo 0.6 mg (NNC0174-0833)

Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type DRUG

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Placebo 0.3 mg (NNC0174-0833)

Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (NNC0174-0833)

Intervention Type DRUG

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Liraglutide 3.0 mg

Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.

Group Type ACTIVE_COMPARATOR

Liraglutide 3.0 mg

Intervention Type DRUG

Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.

Placebo 3.0 mg (Liraglutide)

Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.

Group Type PLACEBO_COMPARATOR

Placebo (Liraglutide 3.0 mg)

Intervention Type DRUG

Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.

Interventions

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NNC0174-0833

Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Intervention Type DRUG

Placebo (NNC0174-0833)

Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.

Intervention Type DRUG

Liraglutide 3.0 mg

Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.

Intervention Type DRUG

Placebo (Liraglutide 3.0 mg)

Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years or older at the time of signing the informed consent.
* Female subject of non-childbearing potential or Male subject who is surgically sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial').
* BMI equal to 30.0 kg/m\^2 or greater or BMI equal to 27.0 kg/m\^2 or greater with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension or dyslipidaemia (to be assessed at the investigator's discretion).

Exclusion Criteria

* HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central laboratory at screening.
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening irrespective of medical records.
Minimum Eligible Age

18 Years

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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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Nature Coast Clinical Research

Crystal River, Florida, United States

Site Status

Jacksonville Center For Clinical Research

Jacksonville, Florida, United States

Site Status

South Broward Research LLC

Pembroke Pines, Florida, United States

Site Status

St Johns Center For Clinical Research

Ponte Vedra, Florida, United States

Site Status

Cedar-Crosse Research Center

Chicago, Illinois, United States

Site Status

Centennial Medical Group

Elkridge, Maryland, United States

Site Status

Infinity Medical Research

North Dartmouth, Massachusetts, United States

Site Status

Rochester Clinical Research, Inc.

Rochester, New York, United States

Site Status

PharmQuest

Greensboro, North Carolina, United States

Site Status

Prestige Clinical Research

Franklin, Ohio, United States

Site Status

Albert J Weisbrot

Mason, Ohio, United States

Site Status

Family Practice Center of Wadsworth, Inc.

Wadsworth, Ohio, United States

Site Status

Lynn Institute of Norman

Norman, Oklahoma, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Spectrum Medical Research, LLC

Gaffney, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Holston Medical Group Pc

Bristol, Tennessee, United States

Site Status

Texas Diabetes & Endocinology

Round Rock, Texas, United States

Site Status

Washington Center For Weight Management And Research,Inc.

Arlington, Virginia, United States

Site Status

National Clinical Research Inc.

Richmond, Virginia, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

C-endo Diabetes & Endocrinology Clinic

Calgary, Alberta, Canada

Site Status

C-endo Diabetes & Endocrinology Clinic

Edmonton, Alberta, Canada

Site Status

The Wharton Medical Clinic Clinical Trials

Hamilton, Ontario, Canada

Site Status

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Site Status

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, , Denmark

Site Status

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, , Denmark

Site Status

StudyCor

Jyväskylä, , Finland

Site Status

Itä-Suomen yliopisto

Kuopio, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Obesity Research Unit

University of Helsinki, , Finland

Site Status

Clinical Research Centre, St. Vincent's University Hospital,

Dublin, , Ireland

Site Status

Tokyo-Eki Center-building Clinic

Tokyo, , Japan

Site Status

Tokyo Center Clinic

Tokyo, , Japan

Site Status

ToCROM Clinic

Tokyo, , Japan

Site Status

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, , Poland

Site Status

Centrum Medyczne Salvia

Katowice, , Poland

Site Status

Centrum Zdrowia Metabolicznego

Poznan, , Poland

Site Status

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, , Serbia

Site Status

Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

Novi Sad, , Serbia

Site Status

FARMOVS (Pty) LTD

Bloemfontein, Free State, South Africa

Site Status

Dr Wilhase's rooms

Boksburg, Gauteng, South Africa

Site Status

Dr R Dulabh

Johannesburg, Gauteng, South Africa

Site Status

Dr Vawda's site

Durban, KwaZulu-Natal, South Africa

Site Status

Dr J Reddy

Durban, KwaZulu-Natal, South Africa

Site Status

The Health Centre

Bradford-on-Avon, , United Kingdom

Site Status

Southmead Hospital

Bristol, , United Kingdom

Site Status

WISDEM Centre

Coventry, , United Kingdom

Site Status

University Hospital Aintree

Liverpool, , United Kingdom

Site Status

Guys Hospital

London, , United Kingdom

Site Status

UCL - Obesity

London, , United Kingdom

Site Status

Clifton Medical Centre

Rotherham, , United Kingdom

Site Status

Countries

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United States Canada Denmark Finland Ireland Japan Poland Serbia South Africa United Kingdom

References

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Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietilainen KH, Rubino D, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021 Dec 11;398(10317):2160-2172. doi: 10.1016/S0140-6736(21)01751-7. Epub 2021 Nov 16.

Reference Type RESULT
PMID: 34798060 (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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U1111-1214-0429

Identifier Type: OTHER

Identifier Source: secondary_id

2018-001945-14

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9838-4433

Identifier Type: -

Identifier Source: org_study_id

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