Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
- Conditions
- OverweightObesity
- Interventions
- Drug: NNC0174-0833Drug: Placebo (NNC0174-0833)Drug: Placebo (Liraglutide 3.0 mg)Drug: Liraglutide 3.0 mg
- Registration Number
- NCT03856047
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 706
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC0174-0833, 4.5 mg NNC0174-0833 Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks. NNC0174-0833, 2.4 mg NNC0174-0833 Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks. NNC0174-0833, 1.2 mg NNC0174-0833 Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks. NNC0174-0833, 0.6 mg NNC0174-0833 Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks. NNC0174-0833 0.3 mg NNC0174-0833 Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. Placebo 0.6 mg (NNC0174-0833) Placebo (NNC0174-0833) Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Placebo 0.3 mg (NNC0174-0833) Placebo (NNC0174-0833) Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks. Placebo 2.4 mg (NNC0174-0833) Placebo (NNC0174-0833) Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Placebo 4.5 mg (NNC0174-0833) Placebo (NNC0174-0833) Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Placebo 1.2 mg (NNC0174-0833) Placebo (NNC0174-0833) Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks. Placebo 3.0 mg (Liraglutide) Placebo (Liraglutide 3.0 mg) Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks. Liraglutide 3.0 mg Liraglutide 3.0 mg Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.
- Primary Outcome Measures
Name Time Method Change in Body Weight (%) From baseline (week 0) to week 26 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks Week 26 Percentage of participants who achieved a weight loss of greater than or equal to (≥) 5% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks Week 26 Percentage of participants who achieved a weight loss ≥ 10% of baseline (week 0) body weight at 26 weeks is presented. The numbers presented are predictions from a logistic regression model.
Change in Body Weight (Kg) From baseline (week 0) to week 26 Change in body weight (Kg) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Waist Circumference From baseline (week 0) to week 26 Change in waist circumference from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Total Cholesterol From baseline (week 0) to week 26 Change in total cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in High Density Lipoprotein (HDL) Cholesterol From baseline (week 0) to week 26 Change in HDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Low Density Lipoprotein (LDL) Cholesterol From baseline (week 0) to week 26 Change in LDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in HbA1c (mmol/Mol) From baseline (week 0) to week 26 Change in HbA1c (measured as millimoles per mole (mmol/mol)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Number of Treatment-emergent Serious Adverse Events (TESAEs) From week 0 to week 32 An AE was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. Serious AE is an AE that resulted in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. All SAEs reported in the below table are TESAEs. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Change in Aldosterone From baseline (week 0) to week 26 Change in aldosterone from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Change in Very Low Density Lipoprotein (VLDL) Cholesterol From baseline (week 0) to week 26 Change in VLDL cholesterol from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Fasting Plasma Glucose (FPG) (mmol/L) From baseline (week 0) to week 26 Change in FPG (measured as mmol/L)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Triglycerides From baseline (week 0) to week 26 Change in triglycerides from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Glycosylated Haemoglobin (HbA1c) (%-Point) From baseline (week 0) to week 26 Change in HbA1c (measured as percentage point of HbA1c) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in FPG (mg/dL) From baseline (week 0) to week 26 Change in FPG (measured as milligrams per decilitre (mg/dL)) from week 0 to week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Change in Fasting Insulin From baseline (week 0) to week 26 In the below table, fasting insulin data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from in-trial period. 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.
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From baseline (week 0) to week 26 Percentage change in HOMA-IR from week 0 to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered Insulin sensitive, 0.5-1.4: considered Healthy, Above 1.8: considered Early insulin resistance; Above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. Endpoint was evaluated based on data from in-trial period. 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 in-trial period.
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta) From baseline (week 0) to week 26 Change between the value of HOMA-beta cell function collected at Week 26 and HOMA-beta cell function collected at Week 0 is presented. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 \* insulin (micro international units per milliliter (µIU/mL)) / fasting plasma glucose (millimoles per liter (mmol/L)) - 3.5. HOMA-beta score ranges from minus infinity to infinity (no limits). The higher the score the better beta-cell function for HOMA-beta. The endpoint was evaluated based on the data from in-trial period. 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.
Number of Treatment-emergent Adverse Events (TEAEs) From week 0 to week 32 An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or used a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide From week 0 to week 32 Number of participants with occurrence of anti-drug antibodies towards cagrilintide from randomisation from week 0 to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The 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. This endpoint is applicable only for the cagrilintide treatment arms.
Change in Diastolic Blood Pressure (DBP) From baseline (week 0) to week 26 Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Change in Systolic Blood Pressure (SBP) From baseline (week 0) to week 26 Blood pressure was measured in a sitting position after 5 minutes of rest. The end point is evaluated while the subject is treatment-adherent. A participant is treatment adherent until the first time of non-adherence defined as: a) the participant has not been dosed with trial product within the prior 14 days; b) the participant has received other weight management drug or bariatric surgery c) the participant has not reached target dose at a pre-specified week d) After the pre-specified evaluation week for the target dose, the participant has not received the target dose +/- 10 % within the prior 14 days. This endpoint is applicable only for the cagrilintide treatment arms.
Change in Pulse From baseline (week 0) to week 26 Change in pulse from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Change in High Sensitivity C-reactive Protein (hsCRP) From baseline (week 0) to week 26 In the below table, hsCRP data at week 0 and at week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity From baseline (week 0) to week 26 Due to the assay development issue faced by the laboratory, the Plasminogen Activator Inhibitor-1 (PAI-1) activity (mg/L) was not performed in the study.
Change in Renin Activity From baseline (week 0) to week 26 Change in renin activity from week 0 to week 26 is presented. The endpoint was evaluated based on the data from on-treatment period which started from the date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least 6 consecutive missed doses for cagrilintide or 6 consecutive weeks of missed dosing with liraglutide.
Trial Locations
- Locations (53)
South Broward Research LLC
🇺🇸Pembroke Pines, Florida, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Texas Diabetes & Endocinology
🇺🇸Round Rock, Texas, United States
Dr J Reddy
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr Vawda's site
🇿🇦Durban, KwaZulu-Natal, South Africa
Turku University Hospital
🇫🇮Turku, Finland
FARMOVS (Pty) LTD
🇿🇦Bloemfontein, Free State, South Africa
ToCROM Clinic
🇯🇵Tokyo, Japan
Family Practice Center of Wadsworth, Inc.
🇺🇸Wadsworth, Ohio, United States
Spectrum Medical Research, LLC
🇺🇸Gaffney, South Carolina, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
St Johns Center For Clinical Research
🇺🇸Ponte Vedra, Florida, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Infinity Medical Research
🇺🇸North Dartmouth, Massachusetts, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Albert J Weisbrot
🇺🇸Mason, Ohio, United States
Itä-Suomen yliopisto
🇫🇮Kuopio, Finland
Holston Medical Group Pc
🇺🇸Bristol, Tennessee, United States
C-endo Diabetes & Endocrinology Clinic
🇨🇦Edmonton, Alberta, Canada
Aarhus Universitetshospital Diabetes og Hormonsygdomme
🇩🇰Aarhus N, Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
🇩🇰Hvidovre, Denmark
StudyCor
🇫🇮Jyväskylä, Finland
Obesity Research Unit
🇫🇮University Of Helsinki, Finland
Tokyo Center Clinic
🇯🇵Tokyo, Japan
Clinical Research Centre, St. Vincent's University Hospital,
🇮🇪Dublin, Ireland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
🇵🇱Bialystok, Poland
Centrum Medyczne Salvia
🇵🇱Katowice, Poland
Endocrinology, Diabetes and Metabolism Diseases Clinic
🇷🇸Belgrade, Serbia
Centrum Zdrowia Metabolicznego
🇵🇱Poznan, Poland
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
🇷🇸Novi Sad, Serbia
Dr Wilhase's rooms
🇿🇦Boksburg, Gauteng, South Africa
Dr R Dulabh
🇿🇦Johannesburg, Gauteng, South Africa
Southmead Hospital
🇬🇧Bristol, United Kingdom
The Health Centre
🇬🇧Bradford-on-Avon, United Kingdom
WISDEM Centre
🇬🇧Coventry, United Kingdom
Guys Hospital
🇬🇧London, United Kingdom
University Hospital Aintree
🇬🇧Liverpool, United Kingdom
Clifton Medical Centre
🇬🇧Rotherham, United Kingdom
UCL - Obesity
🇬🇧London, United Kingdom
University of Calgary
🇨🇦Calgary, Alberta, Canada
Washington Center For Weight Management And Research,Inc.
🇺🇸Arlington, Virginia, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
The Wharton Medical Clinic Clinical Trials
🇨🇦Hamilton, Ontario, Canada
Hamilton Medical Research Group
🇨🇦Hamilton, Ontario, Canada
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
National Clinical Research Inc.
🇺🇸Richmond, Virginia, United States