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
Purpose
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
Conditions
- Obesity
- Type 2 Diabetes
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cagrisema - dose level 1 |
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks. |
|
|
Active Comparator Cagrisema - dose level 2 |
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks. |
|
|
Active Comparator Semaglutide |
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks. |
|
Recruiting Locations
Uni of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Cahaba Research
Pelham, Alabama 35124
Pelham, Alabama 35124
Elligo Health Research Inc
Gilbert, Arizona 85296
Gilbert, Arizona 85296
Velocity Clinical Research-Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Arkansas Clinical Research
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Woodland Int. Research Group
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Headlands Research California, LLC
Escondido, California 92025
Escondido, California 92025
Neighborhood Healthcare
Escondido, California 92025
Escondido, California 92025
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California 91942
La Mesa, California 91942
Clinical Trials Research_Sacramento
Lincoln, California 95648
Lincoln, California 95648
Loma Linda University Faculty Medical Clinics
Loma Linda, California 92354
Loma Linda, California 92354
Pacific Clinical Studies
Los Alamitos, California 90720
Los Alamitos, California 90720
Valley Clinical Trials
Northridge, California 91325
Northridge, California 91325
Desert Oasis Healthcare
Palm Springs, California 92262
Palm Springs, California 92262
Linda Vista Health Care Ctr
San Diego, California 92111
San Diego, California 92111
Velocity Clin Res - Van Nuys
Van Nuys, California 91405
Van Nuys, California 91405
Flourish Research - CA
Walnut Creek, California 94598
Walnut Creek, California 94598
University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
TBMR & Alcanza
Clearwater, Florida 33761
Clearwater, Florida 33761
Northeast Research Institute
Fleming Island, Florida 32003
Fleming Island, Florida 32003
Northeast Research Institute
Jacksonville, Florida 32204
Jacksonville, Florida 32204
Westside Center For Clinical Research
Jacksonville, Florida 32205
Jacksonville, Florida 32205
Bioclinical Research Alliance
Miami, Florida 33155
Miami, Florida 33155
New Horizon Research Center
Miami, Florida 33165
Miami, Florida 33165
South Broward Research LLC
Miramar, Florida 33027
Miramar, Florida 33027
West Orange Endocrinology
Ocoee, Florida 34761
Ocoee, Florida 34761
Oviedo Medical Research, LLC
Oviedo, Florida 32765
Oviedo, Florida 32765
Clinical Trial Services Corp
Pembroke Pines, Florida 33024
Pembroke Pines, Florida 33024
Hope Clin Res & Wellness
Conyers, Georgia 30094
Conyers, Georgia 30094
Center for Adv Res & Education
Gainesville, Georgia 30501
Gainesville, Georgia 30501
Endocrine Research Solutions, Inc
Roswell, Georgia 30076
Roswell, Georgia 30076
North Georgia Clinical Research
Woodstock, Georgia 30189-4255
Woodstock, Georgia 30189-4255
Solaris Clinical Research
Meridian, Idaho 83646
Meridian, Idaho 83646
Cedar-Crosse Research Center
Chicago, Illinois 60607
Chicago, Illinois 60607
Macoupin Fam Practice Ctr, LLP
Gillespie, Illinois 62033
Gillespie, Illinois 62033
Clinical Investigation Spec Gurnee
Gurnee, Illinois 60031
Gurnee, Illinois 60031
Endeavor Health
Skokie, Illinois 60077
Skokie, Illinois 60077
Evanston Premier Hlthcr Res
Skokie, Illinois 60077
Skokie, Illinois 60077
Iowa Diabetes Research
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Alliance for Multispecialty Research
Newton, Kansas 67114
Newton, Kansas 67114
Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas 66606
Topeka, Kansas 66606
The Research Group of Lexington LLC
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Northern Pines Hlth Ctr, PC
Buckley, Michigan 49620
Buckley, Michigan 49620
AES Minneapolis DRS
Richfield, Minnesota 55423
Richfield, Minnesota 55423
Belzoni Clinical Research
Belzoni, Mississippi 39038
Belzoni, Mississippi 39038
Clinical Research Professionals
Chesterfield, Missouri 63005
Chesterfield, Missouri 63005
Amicis Centers of Clinical Research
St Louis, Missouri 63128
St Louis, Missouri 63128
Southgate Medical Group, LLP
West Seneca, New York 14224
West Seneca, New York 14224
PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408
Greensboro, North Carolina 27408
Physician's East Endocrinology
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Carteret Medical Group
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Centricity Rsrch MHCity Multi
Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Piedmont Healthcare/Research
Statesville, North Carolina 28625
Statesville, North Carolina 28625
Accellacare Wilmington
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
Lillestol Research LLC
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Advanced Medical Research
Maumee, Ohio 43537
Maumee, Ohio 43537
Alliance for Multispecialty Research
Norman, Oklahoma 73069
Norman, Oklahoma 73069
Lynn Institute of Norman
Norman, Oklahoma 73072
Norman, Oklahoma 73072
Hatboro Med Associates
Hatboro, Pennsylvania 19040
Hatboro, Pennsylvania 19040
Northeast Endocrine Metabolic Associates
Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
Clinical Res Collaborative
Cumberland, Rhode Island 02864
Cumberland, Rhode Island 02864
Velocity Clinical Research-Gaffney
Gaffney, South Carolina 29340
Gaffney, South Carolina 29340
Spartanburg Medical Research
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Jackson Clinic
Jackson, Tennessee 38305
Jackson, Tennessee 38305
Holston Medical Group
Kingsport, Tennessee 37660
Kingsport, Tennessee 37660
CNS Healthcare
Memphis, Tennessee 38119
Memphis, Tennessee 38119
HealthStar Physicians, PC
Morristown, Tennessee 37813
Morristown, Tennessee 37813
Clinical Research Associates
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Amarillo Med Spec LLP
Amarillo, Texas 79124
Amarillo, Texas 79124
Texas Diab & Endo, P.A.
Austin, Texas 78731
Austin, Texas 78731
Velocity Clinical Research Austin
Austin, Texas 78759
Austin, Texas 78759
Velocity Clin Res, Dallas
Dallas, Texas 75230
Dallas, Texas 75230
North Texas Endocrine Center
Dallas, Texas 75231
Dallas, Texas 75231
Cedar Health Research
Euless, Texas 76040
Euless, Texas 76040
JCCT- Juno NW Houston
Houston, Texas 77040
Houston, Texas 77040
The Endocrine Center
Houston, Texas 77079
Houston, Texas 77079
Medical Colleagues-Texas LLP
Katy, Texas 77450
Katy, Texas 77450
Sante Clinical Research
Kerrville, Texas 78028
Kerrville, Texas 78028
Radiance Clinical Research
Lampasas, Texas 76550
Lampasas, Texas 76550
Aeres Clinical Research
Laredo, Texas 78041
Laredo, Texas 78041
DCOL Ctr for Clin Res
Longview, Texas 75605
Longview, Texas 75605
RGV Endocrine Center
McAllen, Texas 78503
McAllen, Texas 78503
Quality Research Inc
San Antonio, Texas 78209
San Antonio, Texas 78209
AES San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Northeast Clinical Research of San Antonio
San Antonio, Texas 78233
San Antonio, Texas 78233
Consano Clinical Research, LLC
Shavano Park, Texas 78231
Shavano Park, Texas 78231
Mt Olympus Medical Research, LLC
Sugar Land, Texas 77478
Sugar Land, Texas 77478
J.Lewis Research Inc
Salt Lake City, Utah 84109
Salt Lake City, Utah 84109
J.Lewis Research Inc
Salt Lake City, Utah 84121
Salt Lake City, Utah 84121
Diabetes & Endo Tx Specialists
Sandy City, Utah 84093
Sandy City, Utah 84093
J.Lewis Research Inc
South Jordan, Utah 84095
South Jordan, Utah 84095
Health Res of Hampton Roads
Newport News, Virginia 23606
Newport News, Virginia 23606
Tidewater Physicians Multispecialty Group
Newport News, Virginia 23606
Newport News, Virginia 23606
National Clin Res Inc.
Richmond, Virginia 23294
Richmond, Virginia 23294
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S