DRUG
Cagrilintide
Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
Status
Completed
Phase
Phase 3
Enrollment
331
Locations
28
Results
Not posted
Publications
1
Study summary
This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.
Interventions
DRUG
Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
DRUG
Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
DRUG
Participants will receive placebo matched to semaglutide
Timeline
First posted
Apr 14, 2023
Study start
Apr 3, 2023
Primary completion
Jan 17, 2025
Study completion
Mar 7, 2025
Results posted
Not reported
Registry updated
Jan 22, 2026
Outcomes
Relative Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm)
Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as percentage point
Change in VFA Measured by CT Scan in Subset of the Japanese Study Population
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in centimeter square (cm\^2)
Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
Relative Change in Body Weight
Time frame · From baseline (week 0) to week 20
Measured in percentage (%)
Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in kilogram (kg)
Eligibility
Inclusion Criteria: * Male or female * Age greater than to or equal 18 years at the time of signing informed consent * a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m\^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m\^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D Diabetes-related for participant with T2D * Diagnosed with T2D greater than or equal to 180 days before screening * HbA1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors \[AGI\], glinides, sodium-glucose cotransporter 2 inhibitor \[SGLT2i\]), thiazolidinediones, or sulphonylureas \[SU\] as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening Exclusion Criteria: Obesity-related \- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening Glycaemia-related for participant without T2D * HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening * History of type 1 or type 2 diabetes Diabetes-related for participant with T2D * Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m\^2) as measured by central laboratory at screening * Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Study locations
Japan · Taiwan. Showing up to 24 locations stored in the fast local snapshot.
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, Japan
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, Japan
Tsuruma Kaneshiro Diabetes Clinic
Yamato-shi, Kanagawa, Japan
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, Japan
OCROM Clinic_Internal medicine
Suita-shi, Osaka, Japan
Yao Tokushukai General Hospital_Cardiovascular division
Yao-shi, Osaka, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, Japan
The University of Tokyo Hospital, Diabetes and Metabolic
Bunkyo-ku, Tokyo, Japan
Akaicho Clinic
Chiba-shi, Chiba, Japan
Suidoubashi Medical Clinic_Internal Medicine
Chiyoda-ku, Tokyo, Japan
The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
Chuo-ku, Tokyo, Japan
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, Japan
Okabe Clinic
Chuo-ku, Tokyo, Japan
Kawada Clinic
Gunma, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, Japan
Naka Kinen Clinic
Ibaraki, Japan
Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
Numakunai, Japan
Osaka NISHI-UMEDA Clinic_Internal Medicine
Osaka, Japan
Osaka NISHI-UMEDA Clinic
Osaka, Japan
Shinsapporo Seiryou Hospital, General Clinical Department
Sapporo-shi, Hokkaido, Japan
Shinden Higashi Clinic_Internal medicine
Sendai-shi, Miyagi, Japan
Shinden Higashi Clinic
Sendai-shi, Miyagi, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, Japan
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