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

Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0174-0833; Drug: Placebo (NNC0174-0833); Drug: Liraglutide 3.0 mg; Drug: Placebo (Liraglutide 3.0 mg)

• Study Type: Interventional
• Enrollment (Actual): 706
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Novo Nordisk Investigational Site
    • Calgary, Alberta, Canada, T2V 4J2
      • Novo Nordisk Investigational Site
    • Edmonton, Alberta, Canada, T6H 2L4
      • Novo Nordisk Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Novo Nordisk Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Novo Nordisk Investigational Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Novo Nordisk Investigational Site
  • Hvidovre, Denmark, 2650
    • Novo Nordisk Investigational Site
• Finland
  • Jyväskylä, Finland, 40620
    • Novo Nordisk Investigational Site
  • Kuopio, Finland, 70211
    • Novo Nordisk Investigational Site
  • Turku, Finland, 20520
    • Novo Nordisk Investigational Site
  • University Of Helsinki, Finland, 00014
    • Novo Nordisk Investigational Site
• Ireland
  • Dublin, Ireland, DUBLIN 4
    • Novo Nordisk Investigational Site
• Japan
  • Tokyo, Japan, 103-0027
    • Novo Nordisk Investigational Site
  • Tokyo, Japan, 103-0028
    • Novo Nordisk Investigational Site
  • Tokyo, Japan, 160-0008
    • Novo Nordisk Investigational Site
• Poland
  • Bialystok, Poland, 15-281
    • Novo Nordisk Investigational Site
  • Katowice, Poland, 40-001
    • Novo Nordisk Investigational Site
  • Poznan, Poland, 60-589
    • Novo Nordisk Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Novo Nordisk Investigational Site
  • Novi Sad, Serbia, 21000
    • Novo Nordisk Investigational Site
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9300
      • Novo Nordisk Investigational Site
  • Gauteng
    • Boksburg, Gauteng, South Africa, 1466
      • Novo Nordisk Investigational Site
    • Johannesburg, Gauteng, South Africa, 1812
      • Novo Nordisk Investigational Site
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4091
      • Novo Nordisk Investigational Site
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Novo Nordisk Investigational Site
• United Kingdom
  • Bradford-on-Avon, United Kingdom, BA15 1DQ
    • Novo Nordisk Investigational Site
  • Bristol, United Kingdom, BS10 5NB
    • Novo Nordisk Investigational Site
  • Coventry, United Kingdom, CV2 2DX
    • Novo Nordisk Investigational Site
  • Liverpool, United Kingdom, L9 7AL
    • Novo Nordisk Investigational Site
  • London, United Kingdom, SE1 9RT
    • Novo Nordisk Investigational Site
  • London, United Kingdom, WC1E 6JF
    • Novo Nordisk Investigational Site
  • Rotherham, United Kingdom, S65 1DA
    • Novo Nordisk Investigational Site
• United States
  • California
    • Anaheim, California, United States, 92801
      • Novo Nordisk Investigational Site
    • Spring Valley, California, United States, 91978
      • Novo Nordisk Investigational Site
  • Florida
    • Crystal River, Florida, United States, 34429
      • Novo Nordisk Investigational Site
    • Jacksonville, Florida, United States, 32216
      • Novo Nordisk Investigational Site
    • Pembroke Pines, Florida, United States, 33027
      • Novo Nordisk Investigational Site
    • Ponte Vedra, Florida, United States, 32081
      • Novo Nordisk Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Novo Nordisk Investigational Site
  • Maryland
    • Elkridge, Maryland, United States, 21075-6437
      • Novo Nordisk Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Novo Nordisk Investigational Site
  • New York
    • Rochester, New York, United States, 14609
      • Novo Nordisk Investigational Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Novo Nordisk Investigational Site
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Novo Nordisk Investigational Site
    • Mason, Ohio, United States, 45040-6815
      • Novo Nordisk Investigational Site
    • Wadsworth, Ohio, United States, 44281
      • Novo Nordisk Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Novo Nordisk Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Novo Nordisk Investigational Site
    • Gaffney, South Carolina, United States, 29341
      • Novo Nordisk Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • Novo Nordisk Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620-7352
      • Novo Nordisk Investigational Site
  • Texas
    • Round Rock, Texas, United States, 78681
      • Novo Nordisk Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Novo Nordisk Investigational Site
    • Richmond, Virginia, United States, 23294
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0174-0833, 4.5 mg; Patients will receive 4.5 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: 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.
Experimental: NNC0174-0833, 2.4 mg; Patients will receive 2.4 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: 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.
Experimental: NNC0174-0833, 1.2 mg; Patients will receive 1.2 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: 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.
Experimental: NNC0174-0833, 0.6 mg; Patients will receive 0.6 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: 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.
Experimental: NNC0174-0833 0.3 mg; Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.	Drug: 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.
Placebo Comparator: Placebo 2.4 mg (NNC0174-0833); Patients will receive 2.4 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	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.
Placebo Comparator: Placebo 4.5 mg (NNC0174-0833); Patients will receive 4.5 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	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.
Placebo Comparator: Placebo 1.2 mg (NNC0174-0833); Patients will receive 1.2 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	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.
Placebo Comparator: Placebo 0.6 mg (NNC0174-0833); Patients will receive 0.6 mg of placebo (NNC0174-0833) once a week as injections for 26 weeks.	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.
Placebo Comparator: Placebo 0.3 mg (NNC0174-0833); Patients will receive 0.3 mg of NNC0174-0833 once a week as injections for 26 weeks.	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.
Active Comparator: Liraglutide 3.0 mg; Patients will receive 3.0 mg of liraglutide once daily as injections for 26 weeks.	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.
Placebo Comparator: Placebo 3.0 mg (Liraglutide); Patients will receive placebo 3.0 mg(liraglutide) once daily as injections for 26 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 26 Weeks	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.	Week 26
Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 26 Weeks	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.	Week 26
Change in Body Weight (Kg)	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.	From baseline (week 0) to week 26
Change in Waist Circumference	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.	From baseline (week 0) to week 26
Change in Total Cholesterol	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.	From baseline (week 0) to week 26
Change in High Density Lipoprotein (HDL) Cholesterol	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.	From baseline (week 0) to week 26
Change in Low Density Lipoprotein (LDL) Cholesterol	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.	From baseline (week 0) to week 26
Change in Very Low Density Lipoprotein (VLDL) Cholesterol	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.	From baseline (week 0) to week 26
Change in Triglycerides	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.	From baseline (week 0) to week 26
Change in Glycosylated Haemoglobin (HbA1c) (%-Point)	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.	From baseline (week 0) to week 26
Change in HbA1c (mmol/Mol)	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.	From baseline (week 0) to week 26
Change in Fasting Plasma Glucose (FPG) (mmol/L)	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.	From baseline (week 0) to week 26
Change in FPG (mg/dL)	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.	From baseline (week 0) to week 26
Change in Fasting Insulin	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.	From baseline (week 0) to week 26
Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	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.	From baseline (week 0) to week 26
Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)	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.	From baseline (week 0) to week 26
Number of Treatment-emergent Adverse Events (TEAEs)	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.	From week 0 to week 32
Number of Treatment-emergent Serious Adverse Events (TESAEs)	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.	From week 0 to week 32
Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide	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.	From week 0 to week 32
Change in Diastolic Blood Pressure (DBP)	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.	From baseline (week 0) to week 26
Change in Systolic Blood Pressure (SBP)	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.	From baseline (week 0) to week 26
Change in Pulse	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.	From baseline (week 0) to week 26
Change in High Sensitivity C-reactive Protein (hsCRP)	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.	From baseline (week 0) to week 26
Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity	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.	From baseline (week 0) to week 26
Change in Renin Activity	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.	From baseline (week 0) to week 26
Change in Aldosterone	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.	From baseline (week 0) to week 26

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN9838-4433; U1111-1214-0429 (Other Identifier: World Health Organization (WHO)); 2018-001945-14 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No