A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight

NCT06207877 | Completed Phase 1

• 3 other identifiers: NN9838-4695U1111-1286-05852023-504792-24-00
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This research study tests if CagriSema influences food intake, appetite and emptying of the stomach in people with excess body weight. Participant will either get CagriSema (active medicine) or placebo (a dummy medicine), which has no effect on the body. The treatment participants get is decided by chance. The study will last for about 32 weeks.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in energy intake during ad libitum lunch, evening meal and snackbox

  Measured in percentage (%).

  Baseline to Day 156

Secondary Outcomes (22)

• Change in energy intake during ad libitum lunch, evening meal and snackbox

  Baseline to Day 156

• Change in amount of food consumed during ad libitum lunch, evening meal and snackbox

  Baseline to Day 156

• AUC0-5h,para, area under the paracetamol concentration-time curve from 0 to 5 hours after start of standardised meal

  Day 1 and Day 155: 0-5 hour after standardised meal

• AUC0-1h,para, area under the paracetamol concentration-time curve from 0 to 1 hour after start of standardised meal

  Day 1 and Day 155: 0-1 hour after standardised meal

• Cmax,para, maximum observed paracetamol concentration

  Day 1 and Day 155: 0-5 hour after standardised meal

Study Arms (2)

CagriSema

EXPERIMENTAL

Participants will receive dose 1 cagrilintide and dose 2 semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) during the maintenance period of 5 weeks.

Drug: Cagrilintide; Drug: Semaglutide

Placebo

ACTIVE COMPARATOR

Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once-weekly for 21 weeks.

Drug: Placebo

Interventions

Cagrilintide DRUG

Cagrilintide will be administered subcutaneously.

CagriSema

Semaglutide DRUG

Semaglutide will be administered subcutaneously.

CagriSema

Placebo DRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female.
• Aged 18-65 years (both inclusive) at the time of signing informed consent.
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
• Body mass index (BMI) equal to or above 27.0 kilograms per meter square (kg/m\^2) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Glycated haemoglobin (HbA1C) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening.
• History of type 1 or type 2 diabetes mellitus.
• Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Obesity

Interventions

cagrilintide; semaglutide

Condition Hierarchy (Ancestors)

Overweight; 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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: February 23, 2024
• Primary Completion: October 16, 2024
• Study Completion: November 22, 2024
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)