A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
Recruiting · NCT07564414 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
CagrisemaSemaglutide
What this trial is about
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- BMI≥ 35.0 kg/m\^2.
- Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion criteria
- A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records.
- Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.
Where it is running
60 locations listed across 30 US states.
- Uni of Alabama at Birmingham - Birmingham, Alabama, United States
- Cahaba Research - Pelham, Alabama, United States
- Elligo Health Research Inc - Gilbert, Arizona, United States
- Velocity Clinical Research-Phoenix - Phoenix, Arizona, United States
- Arkansas Clinical Research - Little Rock, Arkansas, United States
- Woodland Int. Research Group - Little Rock, Arkansas, United States
- Headlands Research California, LLC - Escondido, California, United States
- Neighborhood Healthcare - Escondido, California, United States
- Diabetes & Endocrine Specialists - La Mesa - La Mesa, California, United States
- Clinical Trials Research_Sacramento - Lincoln, California, United States
- Loma Linda University Faculty Medical Clinics - Loma Linda, California, United States
- Pacific Clinical Studies - Los Alamitos, California, United States
- Valley Clinical Trials - Northridge, California, United States
- Desert Oasis Healthcare - Palm Springs, California, United States
- Linda Vista Health Care Ctr - San Diego, California, United States
- Velocity Clin Res - Van Nuys - Van Nuys, California, United States
- Flourish Research - CA - Walnut Creek, California, United States
- University of Colorado Hospital - Aurora, Colorado, United States
- TBMR & Alcanza - Clearwater, Florida, United States
- Northeast Research Institute - Fleming Island, Florida, United States
- Northeast Research Institute - Jacksonville, Florida, United States
- Westside Center For Clinical Research - Jacksonville, Florida, United States
- Bioclinical Research Alliance - Miami, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- South Broward Research LLC - Miramar, Florida, United States
- West Orange Endocrinology - Ocoee, Florida, United States
- Oviedo Medical Research, LLC - Oviedo, Florida, United States
- Clinical Trial Services Corp - Pembroke Pines, Florida, United States
- Hope Clin Res & Wellness - Conyers, Georgia, United States
- Center for Adv Res & Education - Gainesville, Georgia, United States
- Endocrine Research Solutions, Inc - Roswell, Georgia, United States
- North Georgia Clinical Research - Woodstock, Georgia, United States
- Solaris Clinical Research - Meridian, Idaho, United States
- Cedar-Crosse Research Center - Chicago, Illinois, United States
- Macoupin Fam Practice Ctr, LLP - Gillespie, Illinois, United States
- Clinical Investigation Spec Gurnee - Gurnee, Illinois, United States
- Endeavor Health - Skokie, Illinois, United States
- Evanston Premier Hlthcr Res - Skokie, Illinois, United States
- Iowa Diabetes Research - West Des Moines, Iowa, United States
- Alliance for Multispecialty Research - Newton, Kansas, United States
- Cotton O'Neil Diab & Endo Ctr - Topeka, Kansas, United States
- The Research Group of Lexington LLC - Lexington, Kentucky, United States
- Endo and Metabolic Consultants - Rockville, Maryland, United States
- Northern Pines Hlth Ctr, PC - Buckley, Michigan, United States
- International Diabetes Center - Minneapolis, Minnesota, United States
- AES Minneapolis DRS - Richfield, Minnesota, United States
- Belzoni Clinical Research - Belzoni, Mississippi, United States
- Clinical Research Professionals - Chesterfield, Missouri, United States
- Amicis Centers of Clinical Research - St Louis, Missouri, United States
- Southgate Medical Group, LLP - West Seneca, New York, United States
- PharmQuest Life Sciences LLC - Greensboro, North Carolina, United States
- Physician's East Endocrinology - Greenville, North Carolina, United States
- Carteret Medical Group - Morehead City, North Carolina, United States
- Centricity Rsrch MHCity Multi - Morehead City, North Carolina, United States
- Piedmont Healthcare/Research - Statesville, North Carolina, United States
- Accellacare Wilmington - Wilmington, North Carolina, United States
- Lillestol Research LLC - Fargo, North Dakota, United States
- Plains Clinical Research Center, LLC - Fargo, North Dakota, United States
- Advanced Medical Research - Maumee, Ohio, United States
- Alliance for Multispecialty Research - Norman, Oklahoma, United States
Showing 60 of 303 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →