Investigating the long-term weight loss effects of CagriSema in obese individuals
Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
This study is testing if a new weight loss medication called CagriSema can help people with obesity lose weight and keep it off better than a placebo over three years.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 38 sites (Covina, California and 37 other locations) |
| Trial ID | NCT06780449 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of CagriSema, a new medication developed by Novo Nordisk, in promoting weight loss among individuals with obesity. Participants will be randomly assigned to receive either CagriSema or a placebo for a main phase lasting two years, followed by an extension phase of one year where treatment will be adjusted based on previous assignments. The study aims to determine the long-term impact of CagriSema on weight loss compared to a dummy medicine. Both phases are designed to ensure that neither participants nor study doctors know which treatment is being administered.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a body mass index (BMI) of 35.0 kg/m² or higher.
Not a fit: Patients with a history of type 1 or type 2 diabetes or those with elevated glycated hemoglobin levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for individuals struggling with obesity.
How similar studies have performed: Other studies have shown promising results with similar weight loss medications, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Male or female. * Age above or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2). Exclusion criteria: * Glycated haemoglobin (HbA1c) \>= 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes.
Where this trial is running
Covina, California and 37 other locations
- Valley Clinical Trials — Covina, California, United States (Recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Not_yet_recruiting)
- Yale University School Of Medicine — New Haven, Connecticut, United States (Not_yet_recruiting)
- East West Medical Research Institute_Honolulu — Honolulu, Hawaii, United States (Not_yet_recruiting)
- L-MARC Research Center — Louisville, Kentucky, United States (Recruiting)
- StudyMetrix Research LLC — Saint Peters, Missouri, United States (Recruiting)
- Spartanburg Medical Research — Spartanburg, South Carolina, United States (Recruiting)
- Holston Medical Group_Bristol — Bristol, Tennessee, United States (Recruiting)
- North Texas Endocrine Center — Dallas, Texas, United States (Recruiting)
- Washington Cntr Weight Mgmt — Arlington, Virginia, United States (Withdrawn)
- CHU Helora - Site Warquignies — Boussu, Belgium (Recruiting)
- Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie — Bruxelles, Belgium (Not_yet_recruiting)
- UZA - UZ Antwerpen - Department of Endocrinology — Edegem, Belgium (Recruiting)
- UZ Leuven - Endocrinology — Leuven, Belgium (Recruiting)
- Dr. M.B. Jones Inc — Victoria, British Columbia, Canada (Recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- Premier Clinical Trial Research Network (PCTRN) — Hamilton, Ontario, Canada (Recruiting)
- Alpha Recherche Clinique - Lebourgneuf — Quebec, Canada (Recruiting)
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus — Aarhus, Denmark (Recruiting)
- Sydvestjysk Sygehus Esbjerg — Esbjerg, Denmark (Recruiting)
- Center for Klinisk Metabolisk Forskning — Hellerup, Denmark (Recruiting)
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159 — Hvidovre, Denmark (Recruiting)
- Sjællands Universitetshospital — Køge, Denmark (Recruiting)
- Unidade Local De Saude De Matosinhos E.P.E. — Senhora Da Hora, Matosinhos, Matosinhos, Portugal (Active_not_recruiting)
- APDP - Associação Protectora dos Diabéticos de Portugal — Lisboa, Portugal (Active_not_recruiting)
- APDP - Associação Protectora dos Diabéticos de Portugal — Lisboa, Portugal (Not_yet_recruiting)
- CUF Descobertas — Lisboa, Portugal (Not_yet_recruiting)
- Hospital Cuf Descobertas S.A. — Lisboa, Portugal (Active_not_recruiting)
- Unidade Local de Saude de Sao Joao E.P.E — Porto, Portugal (Active_not_recruiting)
- Hospital Luz Arrabida, S.A. — Vila Nova de Gaia, Portugal (Active_not_recruiting)
- Southmead Hospital — Bristol, United Kingdom (Recruiting)
- Addenbrooke's Hospital_Cambridge — Cambridge, United Kingdom (Recruiting)
- WISDEM Centre — Coventry, United Kingdom (Recruiting)
- University Hospital Aintree — Liverpool, United Kingdom (Recruiting)
- Blizard Institute_Royal London Hospital — London, United Kingdom (Recruiting)
- Joint Clinical Research Facility - Swansea — Swansea, United Kingdom (Recruiting)
- Musgrove Park Hospital — Taunton, United Kingdom (Recruiting)
- Musgrove Park Hospital — Taunton, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.