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Clinical Trials in Australia / NCT07220642
Active, not recruiting Phase 3

Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

NCT07220642 · tracked via the Priya Life Science Australia tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-11-05
Last updated
2026-08-06

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Cagrilintide →Placebo

Cagrilintide: Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo: Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Study summary

This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * Female or male (sex at birth) * Age 18 years or above at the time of signing the informed consent * History of at least one self-reported unsuccessful dietary effort to lose body weight (a\*) * Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*) Exclusion criteria: * History of type 1 or type 2 diabetes (a\*) * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a\*) * Previous dosing of marketed or non-marketed amylin-based compounds (a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Primary outcome measure(s)

  • Relative change in body weight — From baseline (week 0) to end of treatment (week 64)
    Measured as percentage (%).

Trial sites (40)

FacilityCityRegionStatus
Diablo Clinical Research, Inc. Walnut Creek California
Univ of Colorado at Denver Aurora Colorado
Florida Inst For Clin Res LLC Orlando Florida
Oviedo Medical Research, LLC Oviedo Florida
Walgreens - Store 11760 Oak Park Illinois
Midwest Inst For Clin Res Indianapolis Indiana
StudyMetrix Research LLC City of Saint Peters Missouri
PharmQuest Life Sciences LLC Greensboro North Carolina
Selma Medical Associates Winchester Virginia
CIPREC Pueyrredon Buenos Aires Argentina
CEDIC Centro de Investigación Clínica CABA Argentina
Sydney Cardiometabolic Centre Liverpool New South Wales
Hunter Diabetes Centre Merewether New South Wales
G.A. Research Associates Ltd. Moncton New Brunswick
Nova Scotia Hlth Halifax Halifax Nova Scotia
Hamilton Medical Research Group Hamilton Ontario
Wharton Medical Clinic Clinical Trials (Hamilton) Hamilton Ontario
Milestone Research London Ontario
Centricity Research Oshawa Oshawa Ontario
Centricity Research Toronto Toronto Ontario
Centricity Research Mirabel Mirabel Quebec
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec Saint-Herblain France
Centre de Recherche Clinique Portes Du Sud Vénissieux France
InnoDiab Forschung GmbH Essen Germany
Wendisch - Dahl Hamburg - DZHW Hamburg Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH Oldenburg in Holstein Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCS Rome RM
AOUP Giaccone Palermo Palermo Sicily
A.O.U. Bologna_ Policlinico S.Orsola Malpighi Bologna Italy
IRCCS Ospedale San Raffaele Milano Milan Italy
Haukeland Universitetssykehus Bergen Norway
Drammen sykehus - Vestre Viken HF Drammen Norway
St. Olavs Hospital HF_Endokrinologisk avdeling Trondheim Norway
Osteo-Medic s.c. A. Racewicz, J. Supronik Bialystok Poland
Care Clinic Sp. z o. o. Katowice Poland
Terpa Sp. z o.o. Sp. k. Lublin Poland
NBR Polska Tomasz Klodawski Warsaw Poland
Oak Tree Surgery Liskeard Cornwall
North Coast Medical Ltd Newquay Cornwall
Brunel Medical Practice Torquay Devon

More Novo Nordisk A/S trials in Australia

A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A Starting soon
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight Recruiting
AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation Active, not recruiting

Other trials for the same condition

A Trial of HRS-5817 in Obese Participants Active, not recruiting
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Active, not recruiting
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) Recruiting
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION) Recruiting
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220642 on ClinicalTrials.gov ↗ ← All trials in Australia