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

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

NNC0174-0833

Placebo (NNC0174-0833)

Liraglutide 3.0 mg

Placebo (Liraglutide 3.0 mg)

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

NNC0174-0833, 4.5 mg

NNC0174-0833, 2.4 mg

NNC0174-0833, 1.2 mg

NNC0174-0833, 0.6 mg

NNC0174-0833 0.3 mg

Placebo 2.4 mg (NNC0174-0833)

Placebo 4.5 mg (NNC0174-0833)

Placebo 1.2 mg (NNC0174-0833)

Placebo 0.6 mg (NNC0174-0833)

Placebo 0.3 mg (NNC0174-0833)

Liraglutide 3.0 mg

Placebo 3.0 mg (Liraglutide)

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Change in Systolic Blood Pressure (SBP)

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03856047

First Posted

February 25, 2019

Last Updated

July 17, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03856047

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

March 2, 2020 (Actual)

Study Completion Date

March 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Allocation

Randomized

Enrollment

706 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0174-0833, 4.5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

NNC0174-0833, 2.4 mg

Arm Type

Experimental

Arm Description

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

Arm Title

NNC0174-0833, 1.2 mg

Arm Type

Experimental

Arm Description

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

Arm Title

NNC0174-0833, 0.6 mg

Arm Type

Experimental

Arm Description

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

Arm Title

NNC0174-0833 0.3 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo 2.4 mg (NNC0174-0833)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo 4.5 mg (NNC0174-0833)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo 1.2 mg (NNC0174-0833)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo 0.6 mg (NNC0174-0833)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo 0.3 mg (NNC0174-0833)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Liraglutide 3.0 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo 3.0 mg (Liraglutide)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NNC0174-0833

Intervention Description

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

Intervention Name(s)

Placebo (NNC0174-0833)

Intervention Description

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

Intervention Name(s)

Liraglutide 3.0 mg

Intervention Description

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

Intervention Name(s)

Placebo (Liraglutide 3.0 mg)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Body Weight (%)

Description

Time Frame

From baseline (week 0) to week 26

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 26

Title

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

Description

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.

Time Frame

Week 26

Title

Change in Body Weight (Kg)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Waist Circumference

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Total Cholesterol

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in High Density Lipoprotein (HDL) Cholesterol

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Low Density Lipoprotein (LDL) Cholesterol

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Triglycerides

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Glycosylated Haemoglobin (HbA1c) (%-Point)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in HbA1c (mmol/Mol)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Fasting Plasma Glucose (FPG) (mmol/L)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in FPG (mg/dL)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Fasting Insulin

Description

Time Frame

From baseline (week 0) to week 26

Title

Percentage Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Homeostatic Model Assessment of Beta-cell Function (HOMA-beta)

Description

Time Frame

From baseline (week 0) to week 26

Title

Number of Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From week 0 to week 32

Title

Number of Treatment-emergent Serious Adverse Events (TESAEs)

Description

Time Frame

From week 0 to week 32

Title

Number of Participants With Occurrence of Anti-drug Antibodies Towards Cagrilintide

Description

Time Frame

From week 0 to week 32

Title

Change in Diastolic Blood Pressure (DBP)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Systolic Blood Pressure (SBP)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Pulse

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in High Sensitivity C-reactive Protein (hsCRP)

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity

Description

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.

Time Frame

From baseline (week 0) to week 26

Title

Change in Renin Activity

Description

Time Frame

From baseline (week 0) to week 26

Title

Change in Aldosterone

Description

Time Frame

From baseline (week 0) to week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075-6437

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mason

State/Province

Ohio

ZIP/Postal Code

45040-6815

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29341

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620-7352

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2T 5C7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2V 4J2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6H 2L4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Jyväskylä

ZIP/Postal Code

40620

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

University Of Helsinki

ZIP/Postal Code

00014

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0008

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-281

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Katowice

ZIP/Postal Code

40-001

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Poznan

ZIP/Postal Code

60-589

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9300

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Boksburg

State/Province

Gauteng

ZIP/Postal Code

1466

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1812

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Bradford-on-Avon

ZIP/Postal Code

BA15 1DQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

WC1E 6JF

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rotherham

ZIP/Postal Code

S65 1DA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

IPD Sharing URL

http://novonordisk-trials.com

Citations:

PubMed Identifier

34798060

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.

Results Reference

result

Learn more about this trial

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

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

Overweight, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial