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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
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

NCT07564414

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Obesity, Type 2 Diabetes

Interventions: Cagrisema, Semaglutide

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czechia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (303)
  • Birmingham, Alabama, United States
  • Pelham, Alabama, United States
  • Gilbert, Arizona, United States
  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Little Rock, Arkansas, United States
  • Escondido, California, United States
  • Escondido, California, United States
  • La Mesa, California, United States
  • Lincoln, California, United States
  • Loma Linda, California, United States
  • Los Alamitos, California, United States
  • Northridge, California, United States
  • Palm Springs, California, United States
  • San Diego, California, United States
  • Van Nuys, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Clearwater, Florida, United States
  • Fleming Island, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miramar, Florida, United States
  • Ocoee, Florida, United States
  • Oviedo, Florida, United States
  • Pembroke Pines, Florida, United States
  • Conyers, Georgia, United States
  • Gainesville, Georgia, United States
  • + 273 more on CT.gov