Dysautonomia International

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.	Drug: Cagrisema Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator Cagrisema - dose level 2	Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.	Drug: Cagrisema Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator Semaglutide	Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.	Drug: Semaglutide Semaglutide will be administered subcutaneously.

Recruiting Locations

Cahaba Research
Pelham, Alabama 35124

Velocity Clinical Research-Phoenix
Phoenix, Arizona 85006

Arkansas Clinical Research
Little Rock, Arkansas 72205

Headlands Research California, LLC
Escondido, California 92025

Neighborhood Healthcare
Escondido, California 92025

Diabetes & Endocrine Specialists - La Mesa
La Mesa, California 91942

Clinical Trials Research_Sacramento
Lincoln, California 95648

Pacific Clinical Studies
Los Alamitos, California 90720

Valley Clinical Trials
Northridge, California 91325

Desert Oasis Healthcare
Palm Springs, California 92262

Linda Vista Health Care Ctr
San Diego, California 92111

Velocity Clin Res - Van Nuys
Van Nuys, California 91405

Flourish Research - CA
Walnut Creek, California 94598

TBMR & Alcanza
Clearwater, Florida 33761

Northeast Research Institute
Fleming Island, Florida 32003

Northeast Research Institute
Jacksonville, Florida 32204

Bioclinical Research Alliance
Miami, Florida 33155

New Horizon Research Center
Miami, Florida 33165

South Broward Research LLC
Miramar, Florida 33027

West Orange Endocrinology
Ocoee, Florida 34761

Oviedo Medical Research, LLC
Oviedo, Florida 32765

Hope Clin Res & Wellness
Conyers, Georgia 30094

Center for Adv Res & Education
Gainesville, Georgia 30501

Endocrine Research Solutions, Inc
Roswell, Georgia 30076

North Georgia Clinical Research
Woodstock, Georgia 30189-4255

Solaris Clinical Research
Meridian, Idaho 83646

Macoupin Fam Practice Ctr, LLP
Gillespie, Illinois 62033

Clinical Investigation Spec Gurnee
Gurnee, Illinois 60031

Evanston Premier Hlthcr Res
Skokie, Illinois 60077

Alliance for Multispecialty Research
Newton, Kansas 67114

Cotton O'Neil Diab & Endo Ctr
Topeka, Kansas 66606

The Research Group of Lexington LLC
Lexington, Kentucky 40503

Northern Pines Hlth Ctr, PC
Buckley, Michigan 49620

AES Minneapolis DRS
Richfield, Minnesota 55423

Clinical Research Professionals
Chesterfield, Missouri 63005

Amicis Centers of Clinical Research
St Louis, Missouri 63128

Southgate Medical Group, LLP
West Seneca, New York 14224

PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408

Physician's East Endocrinology
Greenville, North Carolina 27834

Carteret Medical Group
Morehead City, North Carolina 28557

Centricity Rsrch MHCity Multi
Morehead City, North Carolina 28557

Piedmont Healthcare/Research
Statesville, North Carolina 28625

Accellacare Wilmington
Wilmington, North Carolina 28401

Lillestol Research LLC
Fargo, North Dakota 58104

Advanced Medical Research
Maumee, Ohio 43537

Alliance for Multispecialty Research
Norman, Oklahoma 73069

Lynn Institute of Norman
Norman, Oklahoma 73072

Hatboro Med Associates
Hatboro, Pennsylvania 19040

Clinical Res Collaborative
Cumberland, Rhode Island 02864

Spartanburg Medical Research
Spartanburg, South Carolina 29303

Jackson Clinic
Jackson, Tennessee 38305

Holston Medical Group
Kingsport, Tennessee 37660

CNS Healthcare
Memphis, Tennessee 38119

HealthStar Physicians, PC
Morristown, Tennessee 37813

Clinical Research Associates
Nashville, Tennessee 37203

Amarillo Med Spec LLP
Amarillo, Texas 79124

Texas Diab & Endo, P.A.
Austin, Texas 78731

Velocity Clinical Research Austin
Austin, Texas 78759

Velocity Clin Res, Dallas
Dallas, Texas 75230

North Texas Endocrine Center
Dallas, Texas 75231

JCCT- Juno NW Houston
Houston, Texas 77040

The Endocrine Center
Houston, Texas 77079

Sante Clinical Research
Kerrville, Texas 78028

Radiance Clinical Research
Lampasas, Texas 76550

Aeres Clinical Research
Laredo, Texas 78041

DCOL Ctr for Clin Res
Longview, Texas 75605

RGV Endocrine Center
McAllen, Texas 78503

Quality Research Inc
San Antonio, Texas 78209

AES San Antonio
San Antonio, Texas 78229

Northeast Clinical Research of San Antonio
San Antonio, Texas 78233

Consano Clinical Research, LLC
Shavano Park, Texas 78231

Mt Olympus Medical Research, LLC
Sugar Land, Texas 77478

J.Lewis Research Inc
Salt Lake City, Utah 84109

J.Lewis Research Inc
Salt Lake City, Utah 84121

J.Lewis Research Inc
South Jordan, Utah 84095

Health Res of Hampton Roads
Newport News, Virginia 23606

Tidewater Physicians Multispecialty Group
Newport News, Virginia 23606

National Clin Res Inc.
Richmond, Virginia 23294

More Details

Status: Recruiting
Sponsor: Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com