Clinical trial NCT03856047: Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
Official title: Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Weight (%)
timeFrame: From baseline (week 0) to week 26
Secondary outcomes:
measure: Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks
timeFrame: Week 26
measure: Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks
timeFrame: Week 26
measure: Change in Body Weight (Kg)
timeFrame: From baseline (week 0) to week 26
measure: Change in Waist Circumference
timeFrame: From baseline (week 0) to week 26
measure: Change in Total Cholesterol
timeFrame: From baseline (week 0) to week 26
measure: Change in High Density Lipoprotein (HDL) Cholesterol
timeFrame: From baseline (week 0) to week 26
measure: Change in Low Density Lipoprotein (LDL) Cholesterol
timeFrame: From baseline (week 0) to week 26
measure: Change in Very Low Density Lipoprotein (VLDL) Cholesterol
timeFrame: From baseline (week 0) to week 26
measure: Change in Triglycerides
timeFrame: From baseline (week 0) to week 26
measure: Change in Glycosylated Haemoglobin (HbA1c) (%-Point)
timeFrame: From baseline (week 0) to week 26
measure: Change in HbA1c (mmol/Mol)
timeFrame: From baseline (week 0) to week 26
measure: Change in Fasting Plasma Glucose (FPG) (mmol/L)
timeFrame: From baseline (week 0) to week 26
measure: Change in FPG (mg/dL)
timeFrame: From baseline (week 0) to week 26
measure: Change in Fasting Insulin
timeFrame: From baseline (week 0) to week 26
measure: Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: From baseline (week 0) to week 26
measure: Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)
timeFrame: From baseline (week 0) to week 26
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From week 0 to week 32
measure: Number of Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From week 0 to week 32
measure: Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide
timeFrame: From week 0 to week 32
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to week 26
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to week 26
measure: Change in Pulse
timeFrame: From baseline (week 0) to week 26
measure: Change in High Sensitivity C-reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to week 26
measure: Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity
timeFrame: From baseline (week 0) to week 26
measure: Change in Renin Activity
timeFrame: From baseline (week 0) to week 26
measure: Change in Aldosterone
timeFrame: From baseline (week 0) to week 26
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research LLC
state: Florida
city: Ponte Vedra
country: United States
facility: St Johns Center For Clinical Research
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mason
country: United States
facility: Albert J Weisbrot
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc.
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Gaffney
country: United States
facility: Spectrum Medical Research, LLC
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group Pc
state: Tennessee
city: Round Rock
country: United States
facility: Texas Diabetes & Endocinology
state: Texas
city: Arlington
country: United States
facility: Washington Center For Weight Management And Research,Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc.
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: C-endo Diabetes & Endocrinology Clinic
state: Alberta
city: Edmonton
country: Canada
facility: C-endo Diabetes & Endocrinology Clinic
state: Alberta
city: Hamilton
country: Canada
facility: The Wharton Medical Clinic Clinical Trials
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital Diabetes og Hormonsygdomme
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital Endokrinologisk forsknings afsnit 159
city: Jyväskylä
country: Finland
facility: StudyCor
city: Kuopio
country: Finland
facility: Itä-Suomen yliopisto
city: Turku
country: Finland
facility: Turku University Hospital
city: University Of Helsinki
country: Finland
facility: Obesity Research Unit
city: Dublin
country: Ireland
facility: Clinical Research Centre, St. Vincent's University Hospital,
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Tokyo Center Clinic
city: Tokyo
country: Japan
facility: ToCROM Clinic
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych
city: Katowice
country: Poland
facility: Centrum Medyczne Salvia
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego
city: Belgrade
country: Serbia
facility: Endocrinology, Diabetes and Metabolism Diseases Clinic
city: Novi Sad
country: Serbia
facility: Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
city: Bloemfontein
country: South Africa
facility: FARMOVS (Pty) LTD
state: Free State
city: Boksburg
country: South Africa
facility: Dr Wilhase's rooms
state: Gauteng
city: Johannesburg
country: South Africa
facility: Dr R Dulabh
state: Gauteng
city: Durban
country: South Africa
facility: Dr Vawda's site
state: KwaZulu-Natal
city: Durban
country: South Africa
facility: Dr J Reddy
state: KwaZulu-Natal
city: Bradford-on-Avon
country: United Kingdom
facility: The Health Centre
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Coventry
country: United Kingdom
facility: WISDEM Centre
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
city: London
country: United Kingdom
facility: Guys Hospital
city: London
country: United Kingdom
facility: UCL - Obesity
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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.