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

NCT03856047 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: NN9838-4433U1111-1214-04292018-001945-14
• Study Type: interventional
• Target: 706
• Locations: 10 countries
• Sites: 54

Brief Summary

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight (%)

  Change in body weight (%) from week 0 to week 26 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period and treatment adherent period, respectively. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Follow-up time for positive antibodies was not included in the in-trial period. Treatment-adherent: a participant is treatment adherent until the first time of non-adherence defined as: participant has not been dosed with trial product within the prior 14 days; participant has received other weight management drug or bariatric surgery; participant has not reached target dose at a pre-specified week; After the pre-specified evaluation week for the target dose, the participant has not received the target dose ±10% within the prior 14 days.

  From baseline (week 0) to week 26

Secondary Outcomes (26)

• Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks

  Week 26

• Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks

  Week 26

• Change in Body Weight (Kg)

  From baseline (week 0) to week 26

• Change in Waist Circumference

  From baseline (week 0) to week 26

• Change in Total Cholesterol

  From baseline (week 0) to week 26

Study Arms (12)

NNC0174-0833, 4.5 mg

EXPERIMENTAL

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

Drug: NNC0174-0833

NNC0174-0833, 2.4 mg

EXPERIMENTAL

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

Drug: NNC0174-0833

NNC0174-0833, 1.2 mg

EXPERIMENTAL

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

Drug: NNC0174-0833

NNC0174-0833, 0.6 mg

EXPERIMENTAL

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

Drug: NNC0174-0833

NNC0174-0833 0.3 mg

EXPERIMENTAL

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

Drug: NNC0174-0833

Placebo 2.4 mg (NNC0174-0833)

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0174-0833)

Placebo 4.5 mg (NNC0174-0833)

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0174-0833)

Placebo 1.2 mg (NNC0174-0833)

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0174-0833)

Placebo 0.6 mg (NNC0174-0833)

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0174-0833)

Placebo 0.3 mg (NNC0174-0833)

PLACEBO COMPARATOR

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

Drug: Placebo (NNC0174-0833)

Liraglutide 3.0 mg

ACTIVE COMPARATOR

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

Drug: Liraglutide 3.0 mg

Placebo 3.0 mg (Liraglutide)

PLACEBO COMPARATOR

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

Drug: Placebo (Liraglutide 3.0 mg)

Interventions

NNC0174-0833 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; NNC0174-0833, 0.6 mg; NNC0174-0833, 1.2 mg; NNC0174-0833, 2.4 mg; NNC0174-0833, 4.5 mg

Placebo (NNC0174-0833) 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); Placebo 0.6 mg (NNC0174-0833); Placebo 1.2 mg (NNC0174-0833); Placebo 2.4 mg (NNC0174-0833); Placebo 4.5 mg (NNC0174-0833)

Liraglutide 3.0 mg 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.

Liraglutide 3.0 mg

Placebo (Liraglutide 3.0 mg) 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.

Placebo 3.0 mg (Liraglutide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (54)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32216, United States

Location

South Broward Research LLC

Pembroke Pines, Florida, 33027, United States

Location

St Johns Center For Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075-6437, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Prestige Clinical Research

Franklin, Ohio, 45005, United States

Location

Albert J Weisbrot

Mason, Ohio, 45040-6815, United States

Location

Family Practice Center of Wadsworth, Inc.

Wadsworth, Ohio, 44281, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73069, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spectrum Medical Research, LLC

Gaffney, South Carolina, 29341, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group Pc

Bristol, Tennessee, 37620-7352, United States

Location

Texas Diabetes & Endocinology

Round Rock, Texas, 78681, United States

Location

Washington Center For Weight Management And Research,Inc.

Arlington, Virginia, 22206, United States

Location

National Clinical Research Inc.

Richmond, Virginia, 23294, United States

Location

University of Calgary

Calgary, Alberta, T2T 5C7, Canada

Location

C-endo Diabetes & Endocrinology Clinic

Calgary, Alberta, T2V 4J2, Canada

Location

C-endo Diabetes & Endocrinology Clinic

Edmonton, Alberta, T6H 2L4, Canada

Location

The Wharton Medical Clinic Clinical Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Hamilton Medical Research Group

Hamilton, Ontario, L8M 1K7, Canada

Location

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, 8200, Denmark

Location

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650, Denmark

Location

StudyCor

Jyväskylä, 40620, Finland

Location

Itä-Suomen yliopisto

Kuopio, 70211, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Obesity Research Unit

University of Helsinki, 00014, Finland

Location

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

Dublin, DUBLIN 4, Ireland

Location

Tokyo-Eki Center-building Clinic

Tokyo, 103-0027, Japan

Location

Tokyo Center Clinic

Tokyo, 103-0028, Japan

Location

ToCROM Clinic

Tokyo, 160-0008, Japan

Location

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, 15-281, Poland

Location

Centrum Medyczne Salvia

Katowice, 40-001, Poland

Location

Centrum Zdrowia Metabolicznego

Poznan, 60-589, Poland

Location

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, 11000, Serbia

Location

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

Novi Sad, 21000, Serbia

Location

FARMOVS (Pty) LTD

Bloemfontein, Free State, 9300, South Africa

Location

Dr Wilhase's rooms

Boksburg, Gauteng, 1466, South Africa

Location

Dr R Dulabh

Johannesburg, Gauteng, 1812, South Africa

Location

Dr Vawda's site

Durban, KwaZulu-Natal, 4091, South Africa

Location

Dr J Reddy

Durban, KwaZulu-Natal, 4450, South Africa

Location

The Health Centre

Bradford-on-Avon, BA15 1DQ, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

WISDEM Centre

Coventry, CV2 2DX, United Kingdom

Location

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

Location

Guys Hospital

London, SE1 9RT, United Kingdom

Location

UCL - Obesity

London, WC1E 6JF, United Kingdom

Location

Clifton Medical Centre

Rotherham, S65 1DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34798060 RESULT

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Clinical Reporting Anchor and Disclosure (1452)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: March 1, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 25, 2021
• Last Updated: July 5, 2024
• Results First Posted: July 18, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (22); JP (3); PL (3); IE (1); CA (5); FI (4); ZA (5); SE (2); GB (7); DK (2)