← Trials/Trial dossier/NCT03856047

CompletedPhase 2Results posted

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.

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Liraglutide

Listed sites

54

Recruiting sites

Enrollment

706

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03856047
Org study IDNN9838-4433
Secondary ID2018-001945-14European Medicines Agency (EudraCT)
Secondary IDU1111-1214-0429World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-02-27actual
Study start2019-03-01actual
Primary completion2020-03-02actual
Study completion2021-03-25actual
Results first posted2023-07-18actual
Last update posted2024-07-05actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
22
Glycemic / diabetes
14
Weight & body composition
10
Safety / tolerability / PK
6
Other (unclassified)
2

Weight & body composition

10 endpoints
Primary/registry result

Change in Body Weight (%)

Time frame:From baseline (week 0) to week 26

Body weight, % change

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage point of body weight95% CI
Cagrilintide 0.3 mg-6.1
Cagrilintide 0.6 mg-6.9
Cagrilintide 1.2 mg-8.5
Cagrilintide 2.4 mg-9.5
Cagrilintide 4.5 mg-10.8
Liraglutide 3.0 mg-8.5
Pooled Placebo-3.0
Treatment difference (%-points)-2.9995% CI-4.58-1.40p0.0002ANCOVA
Treatment difference (%-points)-3.7895% CI-5.38-2.17p<.0001ANCOVA
Treatment difference (%-points)-6.0795% CI-7.77-4.36p<.0001ANCOVA
Treatment difference (%-points)-6.6895% CI-8.28-5.09p<.0001ANCOVA
Treatment difference (%-points)-7.7995% CI-9.42-6.16p<.0001ANCOVA
Treatment difference (%-points)-5.9895% CI-7.61-4.35p<.0001ANCOVA
Treatment difference (%-points)2.9995% CI1.384.60p0.0003ANCOVA
Treatment difference (%-points)2.2095% CI0.573.84p0.0082ANCOVA
Treatment difference (%-points)-0.0995% CI-1.821.64p0.9209ANCOVA
Treatment difference (%-points)-0.7095% CI-2.330.92p0.3960ANCOVA
Treatment difference (%-points)-1.8195% CI-3.46-0.16p0.0316ANCOVA
Primary/protocol endpoint

Change in Body Weight (%)

Time frame:From baseline (week 0) to week 26

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

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

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Cagrilintide 0.3 mg57.47
Cagrilintide 0.6 mg61.98
Cagrilintide 1.2 mg75.84
Cagrilintide 2.4 mg74.12
Cagrilintide 4.5 mg88.74
Liraglutide 3.0 mg76.16
Pooled Placebo30.90
Secondary/registry result

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

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), Percentage of participants95% CI
Cagrilintide 0.3 mg15.28
Cagrilintide 0.6 mg24.06
Cagrilintide 1.2 mg35.79
Cagrilintide 2.4 mg43.97
Cagrilintide 4.5 mg53.49
Liraglutide 3.0 mg39.43
Pooled Placebo10.44
Secondary/registry result

Change in Body Weight (Kg)

Time frame:From baseline (week 0) to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), Kilograms (kg)95% CI
Cagrilintide 0.3 mg-6.6
Cagrilintide 0.6 mg-7.1
Cagrilintide 1.2 mg-9.0
Cagrilintide 2.4 mg-10.1
Cagrilintide 4.5 mg-11.8
Liraglutide 3.0 mg-9.1
Pooled Placebo-3.2
Secondary/registry result

Change in Waist Circumference

Time frame:From baseline (week 0) to week 26

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), centimeters (cm)95% CI
Cagrilintide 0.3 mg-6.2
Cagrilintide 0.6 mg-6.2
Cagrilintide 1.2 mg-7.7
Cagrilintide 2.4 mg-8.1
Cagrilintide 4.5 mg-9.5
Liraglutide 3.0 mg-7.4
Pooled Placebo-3.4
Secondary/protocol endpoint

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

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight (Kg)

Time frame:From baseline (week 0) to week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:From baseline (week 0) to week 26

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

14 endpoints
Secondary/registry result

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

Time frame:From baseline (week 0) to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), Percentage point of HbA1c95% CI
Cagrilintide 0.3 mg0.0
Cagrilintide 0.6 mg-0.1
Cagrilintide 1.2 mg-0.1
Cagrilintide 2.4 mg-0.1
Cagrilintide 4.5 mg-0.1
Liraglutide 3.0 mg-0.3
Pooled Placebo-0.1
Secondary/registry result

Change in HbA1c (mmol/Mol)

Time frame:From baseline (week 0) to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), mmol/mol95% CI
Cagrilintide 0.3 mg-0.5
Cagrilintide 0.6 mg-0.6
Cagrilintide 1.2 mg-0.8
Cagrilintide 2.4 mg-1.0
Cagrilintide 4.5 mg-1.2
Liraglutide 3.0 mg-2.9
Pooled Placebo-0.6
Secondary/registry result

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

Time frame:From baseline (week 0) to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mmol/L95% CI
Cagrilintide 0.3 mg0.0
Cagrilintide 0.6 mg0.0
Cagrilintide 1.2 mg-0.2
Cagrilintide 2.4 mg0.0
Cagrilintide 4.5 mg-0.2
Liraglutide 3.0 mg-0.5
Pooled Placebo0.0
Secondary/registry result

Change in FPG (mg/dL)

Time frame:From baseline (week 0) to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Cagrilintide 0.3 mg-0.7
Cagrilintide 0.6 mg-0.6
Cagrilintide 1.2 mg-3.2
Cagrilintide 2.4 mg0.0
Cagrilintide 4.5 mg-3.7
Liraglutide 3.0 mg-9.5
Pooled Placebo-0.5
Secondary/registry result

Change in Fasting Insulin

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Posted result

GroupValue (mean), Picomoles per liter (pmol/L)95% CI
Cagrilintide 0.3 mgWeek 0103.88
Week 2693.07
Cagrilintide 0.6 mgWeek 097.43
Week 2682.98
Cagrilintide 1.2 mgWeek 096.44
Week 2679.39
Cagrilintide 2.4 mgWeek 090.05
Week 2671.22
Cagrilintide 4.5 mgWeek 0109.99
Week 2678.67
Liraglutide 3.0 mgWeek 095.80
Week 2679.00
Pooled PlaceboWeek 0105.77
Week 2686.55
Secondary/registry result

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

Time frame:From baseline (week 0) to week 26

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Posted result

GroupValue (mean), Percentage change of HOMA-IR95% CI
Cagrilintide 0.3 mg-0.05
Cagrilintide 0.6 mg-0.60
Cagrilintide 1.2 mg-1.09
Cagrilintide 2.4 mg-0.72
Cagrilintide 4.5 mg-2.12
Liraglutide 3.0 mg-0.91
Pooled Placebo-0.71
Secondary/registry result

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

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Posted result

GroupValue (mean), Percentage of Beta Cell Function95% CI
Cagrilintide 0.3 mg-10.7
Cagrilintide 0.6 mg-20.0
Cagrilintide 1.2 mg-18.3
Cagrilintide 2.4 mg-29.9
Cagrilintide 4.5 mg-39.7
Liraglutide 3.0 mg16.3
Pooled Placebo-26.0
Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c (mmol/Mol)

Time frame:From baseline (week 0) to week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in FPG (mg/dL)

Time frame:From baseline (week 0) to week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Change in Fasting Insulin

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to week 26

HOMA-IR (insulin sensitivity)

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Cardiometabolic biomarkers

22 endpoints
Secondary/registry result

Change in Total Cholesterol

Time frame:From baseline (week 0) to week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

GroupValue (mean), Milligrams per deciliter (mg/dL)95% CI
Cagrilintide 0.3 mg3.9
Cagrilintide 0.6 mg-1.8
Cagrilintide 1.2 mg-3.1
Cagrilintide 2.4 mg-2.9
Cagrilintide 4.5 mg-5.4
Liraglutide 3.0 mg-9.4
Pooled Placebo0.1
Secondary/registry result

Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:From baseline (week 0) to week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

GroupValue (mean), mg/dL95% CI
Cagrilintide 0.3 mg1.5
Cagrilintide 0.6 mg1.9
Cagrilintide 1.2 mg1.1
Cagrilintide 2.4 mg1.8
Cagrilintide 4.5 mg2.6
Liraglutide 3.0 mg0.8
Pooled Placebo0.1
Secondary/registry result

Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:From baseline (week 0) to week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

GroupValue (mean), mg/dL95% CI
Cagrilintide 0.3 mg5.2
Cagrilintide 0.6 mg-0.3
Cagrilintide 1.2 mg-0.5
Cagrilintide 2.4 mg-0.9
Cagrilintide 4.5 mg-2.7
Liraglutide 3.0 mg-5.4
Pooled Placebo-1.0
Secondary/registry result

Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:From baseline (week 0) to week 26

VLDL, change

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Cagrilintide 0.3 mg-2.8
Cagrilintide 0.6 mg-3.4
Cagrilintide 1.2 mg-3.6
Cagrilintide 2.4 mg-3.8
Cagrilintide 4.5 mg-5.4
Liraglutide 3.0 mg-4.9
Pooled Placebo0.9
Secondary/registry result

Change in Triglycerides

Time frame:From baseline (week 0) to week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

GroupValue (mean), mg/dL95% CI
Cagrilintide 0.3 mg-13.29
Cagrilintide 0.6 mg-16.25
Cagrilintide 1.2 mg-17.98
Cagrilintide 2.4 mg-19.24
Cagrilintide 4.5 mg-30.35
Liraglutide 3.0 mg-25.42
Pooled Placebo8.17
Secondary/registry result

Change in Diastolic Blood Pressure (DBP)

Time frame:From baseline (week 0) to week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), millimeter of mercury (mmHg)95% CI
Cagrilintide 0.3 mg-2.2
Cagrilintide 0.6 mg0.8
Cagrilintide 1.2 mg-1.3
Cagrilintide 2.4 mg-1.2
Cagrilintide 4.5 mg-1.8
Pooled Placebo-2.6
Secondary/registry result

Change in Systolic Blood Pressure (SBP)

Time frame:From baseline (week 0) to week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), mmHg95% CI
Cagrilintide 0.3 mg-4.9
Cagrilintide 0.6 mg-0.9
Cagrilintide 1.2 mg-4.9
Cagrilintide 2.4 mg-5.0
Cagrilintide 4.5 mg-6.2
Pooled Placebo-3.8
Secondary/registry result

Change in Pulse

Time frame:From baseline (week 0) to week 26

Heart rate, change

change from baseline, improvement

Posted result

GroupValue (mean), beats per minute95% CI
Cagrilintide 0.3 mg-2.1
Cagrilintide 0.6 mg-0.6
Cagrilintide 1.2 mg-1.2
Cagrilintide 2.4 mg-2.0
Cagrilintide 4.5 mg-4.5
Liraglutide 3.0 mg1.6
Pooled Placebo-0.1
Secondary/registry result

Change in High Sensitivity C-reactive Protein (hsCRP)

Time frame:From baseline (week 0) to week 26

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

GroupValue (mean), milligrams per liter (mg/L)95% CI
Cagrilintide 0.3 mgWeek 04.5
Week 263.5
Cagrilintide 0.6 mgWeek 04.6
Week 263.4
Cagrilintide 1.2 mgWeek 04.5
Week 264.6
Cagrilintide 2.4 mgWeek 05.8
Week 264.0
Cagrilintide 4.5 mgWeek 05.4
Week 263.4
Liraglutide 3.0 mgWeek 04.7
Week 263.5
Pooled PlaceboWeek 04.6
Week 263.9
Secondary/registry result

Change in Renin Activity

Time frame:From baseline (week 0) to week 26

change from baseline, descriptive

Posted result

GroupValue (mean), nanograms per milliliter per hour95% CI
Cagrilintide 0.3 mg2
Cagrilintide 0.6 mg0
Cagrilintide 1.2 mg1
Cagrilintide 2.4 mg1
Cagrilintide 4.5 mg1
Liraglutide 3.0 mg0
Pooled Placebo0
Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:From baseline (week 0) to week 26

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol

Time frame:From baseline (week 0) to week 26

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol

Time frame:From baseline (week 0) to week 26

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:From baseline (week 0) to week 26

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:From baseline (week 0) to week 26

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP)

Time frame:From baseline (week 0) to week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP)

Time frame:From baseline (week 0) to week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Pulse

Time frame:From baseline (week 0) to week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP)

Time frame:From baseline (week 0) to week 26

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Renin Activity

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in Aldosterone

Time frame:From baseline (week 0) to week 26

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:From week 0 to week 32

Treatment-emergent AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Cagrilintide 0.3 mg335
Cagrilintide 0.6 mg291
Cagrilintide 1.2 mg361
Cagrilintide 2.4 mg449
Cagrilintide 4.5 mg460
Liraglutide 3.0 mg470
Pooled Placebo276
Secondary/registry result

Number of Treatment-emergent Serious Adverse Events (TESAEs)

Time frame:From week 0 to week 32

Serious AEs (any)

event count, event

Posted result

GroupValue (number), Events95% CI
Cagrilintide 0.3 mg8
Cagrilintide 0.6 mg3
Cagrilintide 1.2 mg8
Cagrilintide 2.4 mg6
Cagrilintide 4.5 mg4
Liraglutide 3.0 mg4
Pooled Placebo4
Secondary/registry result

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

Time frame:From week 0 to week 32

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupValue (count_of_participants), Participants95% CI
Cagrilintide 0.3 mg51
Cagrilintide 0.6 mg54
Cagrilintide 1.2 mg52
Cagrilintide 2.4 mg75
Cagrilintide 4.5 mg75
Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:From week 0 to week 32

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Serious Adverse Events (TESAEs)

Time frame:From week 0 to week 32

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:From week 0 to week 32

Immunogenicity (ADA)

threshold achievement, event

Other (unclassified)

2 endpoints
Secondary/registry result/low confidence

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

Time frame:From baseline (week 0) to week 26

change from baseline, descriptive

Secondary/registry result/low confidence

Change in Aldosterone

Time frame:From baseline (week 0) to week 26

change from baseline, descriptive

Posted result

GroupValue (mean), nanograms per deciliter (ng/dL)95% CI
Cagrilintide 0.3 mg0.8
Cagrilintide 0.6 mg0.8
Cagrilintide 1.2 mg0.7
Cagrilintide 2.4 mg2.2
Cagrilintide 4.5 mg1.1
Liraglutide 3.0 mg1.0
Pooled Placebo0.5

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.