Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
300
Countries
2
Sites
8
Obesity
To confirm superiority on body weight reduction of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo as an adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity.
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 5 Sep 2024 → 23 Apr 2026
- Decision date (initial)
- 2024-06-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-509273-24-00
- WHO UTN
- U1111-1298-3451
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To confirm superiority on body weight reduction of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo as an adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity.
Secondary objectives 4
- "To confirm superiority of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo on achievement of ≥10% weight reduction."
- To confirm superiority of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo on achievement of ≥15% weight reduction.
- To confirm superiority of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo on waist circumference
- "To confirm superiority of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo on achievement of ≥20% weight reduction."
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- a) BMI ≥30.0 kg/m2a or b) BMI ≥27.0 kg/m2a with the presence of at least one obesity-related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Exclusion criteria 2
- HbA1c ≥6.5% (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Relative change in body weight
- Achievement of ≥5% weight reduction
Secondary endpoints 6
- Achievement of ≥10 % weight reduction
- Achievement of ≥15% weight reduction
- Achievement of ≥20% weight reduction
- Change in waist circumference
- Change in systolic blood pressure
- Ratio to baselin in lipids: Total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Triglycerids, Free fatty acids
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD8977530 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 56 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977527 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977528 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD8977529 · Product
- Active substance
- Cagrilintide
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU submission Hub
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| SYRINX Bioanalytics Oy ORG-100021026
|
Turku, Finland | Other |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Laboratory analysis |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Other |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Other |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other |
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 3 |
| Germany | Ended | 60 | 5 |
| Rest of world
Canada, United Kingdom, United States
|
— | 200 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
N/A, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Toulouse
N/A, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Hospices Civils De Lyon
N/A, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Wendisch/Dahl Hamburg
N/A, Gemeinschaftspraxis für Innere Medizin, Beselerstr. 2a, Hamburg
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
KliFoCenter GmbH
N/A, Diakonissenstrasse 8, Mitte, Witten
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-09-05 | 2026-04-17 | 2024-09-11 | 2024-11-13 | |
| Germany | 2024-09-05 | 2026-04-22 | 2024-09-10 | 2024-11-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_nn9838-7749-protocol-2023-509273-24-english_for-publication | 5 |
| Recruitment arrangements (for publication) | K1_DE-NN9838-7749-Recruitment Arrangements and Informed consent procedure_For Publication | 1.0 |
| Recruitment arrangements (for publication) | K1_FR_NN9838-7749-Recruitment Arrangements and Informed consent procedure_For Publication | 1.1 |
| Recruitment arrangements (for publication) | K2_DE NN9838-7749 Other Info to Subjects-Study leaflet_For publication | 2.0 |
| Recruitment arrangements (for publication) | K2_DE-NN9838-7749-Advertisement recruitment poster_For Publication | 2.0 |
| Recruitment arrangements (for publication) | K2_FR_NN9838-7749-Advertisement recruitment poster_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-7749 SI-IC Future Research_For publication | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-7749 SI-IC Male Partner_For publication | 1.1 |
| Subject information and informed consent form (for publication) | l1_de-nn9838-7749-piic-adult-_for-publication | 3 |
| Subject information and informed consent form (for publication) | L1_FR_NN9838-7749 SI-IC Future Research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_FR_NN9838-7749 SI-IC Male Partner_For publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_fr-nn9838-7749-piic-main-_for-publication | 3 |
| Subject information and informed consent form (for publication) | L2_FR_NN9838-7749 Other Info to Subjects-Study leaflet_For publication | 1.0 |
| Synopsis of the protocol (for publication) | d1_fr_nn9838-7749-protocol-synopsis-2023-509273-24-french-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_nn9838-7749-protocol-synopsis-2023-509273-24-english_for-publication | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-11 | Germany | Acceptable with conditions 2024-06-24
|
2024-06-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-11 | Germany | Acceptable 2024-09-02
|
2024-09-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-26 | Germany | Acceptable 2024-11-06
|
2024-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-10 | Germany | Acceptable 2025-02-20
|
2025-02-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-18 | Germany | Acceptable 2025-09-16
|
2025-09-16 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-21 | Germany | Acceptable 2026-02-27
|
2026-03-02 |