A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

NCT05813925 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN9838-4762U1111-1277-3764jRCT2031220734
• Study Type: interventional
• Target: 331
• Locations: 2 countries
• Sites: 28

Brief 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.

Conditions

Obesity or Overweight

Outcome Measures

Primary Outcomes (1)

• Relative Change in Body Weight

  Measured in percentage (%)

  From baseline (week 0) to end of treatment (week 68)

Secondary Outcomes (25)

• Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

  From baseline (week 0) to end of treatment (week 68)

• Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline

  From baseline (week 0) to end of treatment (week 68)

• Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population

  From baseline (week 0) to end of treatment (week 68)

• Change in VFA Measured by CT Scan in Subset of the Japanese Study Population

  From baseline (week 0) to end of treatment (week 68)

• 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)

  From baseline (week 0) to end of treatment (week 68)

Study Arms (2)

CagriSema 2.4 mg/2.4 mg

EXPERIMENTAL

Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks

Drug: Cagrilintide; Drug: Semaglutide

Semaglutide 2.4 mg

ACTIVE COMPARATOR

Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks

Drug: Semaglutide; Drug: Placebo Semaglutide

Interventions

Cagrilintide DRUG

Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

CagriSema 2.4 mg/2.4 mg

Semaglutide DRUG

Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

CagriSema 2.4 mg/2.4 mg; Semaglutide 2.4 mg

Placebo Semaglutide DRUG

Participants will receive placebo matched to semaglutide

Semaglutide 2.4 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (28)

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan

Location

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, 880-0034, Japan

Location

OCROM Clinic_Internal medicine

Suita-shi, Osaka, 565-0853, Japan

Location

Yao Tokushukai General Hospital_Cardiovascular division

Yao-shi, Osaka, 581-0011, Japan

Location

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, 468-0009, Japan

Location

The University of Tokyo Hospital, Diabetes and Metabolic

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Akaicho Clinic

Chiba-shi, Chiba, 260-0804, Japan

Location

Suidoubashi Medical Clinic_Internal Medicine

Chiyoda-ku, Tokyo, 101-0065, Japan

Location

The Institute of Medical Science, Asahi Life Foundation_Internal Medicine

Chuo-ku, Tokyo, 103-0002, Japan

Location

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, 103-0002, Japan

Location

Okabe Clinic

Chuo-ku, Tokyo, 104-0061, Japan

Location

Kawada Clinic

Gunma, 373-0036, Japan

Location

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

Location

Naka Kinen Clinic

Ibaraki, 311-0113, Japan

Location

Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine

Numakunai, 020-8505, Japan

Location

Osaka NISHI-UMEDA Clinic_Internal Medicine

Osaka, 530-0001, Japan

Location

Osaka NISHI-UMEDA Clinic

Osaka, 530-0001, Japan

Location

Shinsapporo Seiryou Hospital, General Clinical Department

Sapporo-shi, Hokkaido, 004-0004, Japan

Location

Shinden Higashi Clinic_Internal medicine

Sendai-shi, Miyagi, 983-0039, Japan

Location

Shinden Higashi Clinic

Sendai-shi, Miyagi, 983-0039, Japan

Location

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

Location

Fukuwa Clinic_Internal Medicine

Tokyo, 104-0031, Japan

Location

Fukuwa Clinic

Tokyo, 104-0031, Japan

Location

ToCROM Clinic_Internal Medicine

Tokyo, 160-0008, Japan

Location

Minamino Cardiovascular Hospital_Cardiovascular medicine

Tokyo, 192-0918, Japan

Location

National Taiwan University Hospital_main

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

cagrilintide; semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency' (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: April 3, 2023
• Primary Completion: January 17, 2025
• Study Completion: March 7, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (27); TW (1)