A Study of How CagriSema Works on Appetite in People With Excess Body Weight

NCT06267092 | Completed Phase 1 FDA Drug

• 1 other identifier: NN9838-4944
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Part A: The study will look at participants appetite and energy intake and also look at the mechanisms of brain associated with appetite and food intake. Participants will not get any medicine and will be in a group that will be compared to another group receiving a weight-loss medicine. The study will last for about 6 months. Part B: The study will look at how CagriSema works on participants appetite and energy intake and will be compared with a ''dummy'' medicine. The study will also look at how participants brain works when participants take the medicine. Participants will either get CagriSema or ''dummy'' medicine.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• Change in mean postprandial appetite score based on visual analogue scale (VAS)

  Measured in millimeter. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.

  Baseline to week 24

Secondary Outcomes (10)

• Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption

  Baseline to week 24

• Change in average DAILY EATS questionnaire scores over one week for: average hunger, worst hunger, appetite, cravings, satiety and eating drivers index composite score

  Baseline pre-treatment ((Day 4 - Day 10) to treatment (Day 156 - Day 162))

• Change in control of eating questionnaire (COEQ), 4 domains: craving control score, positive mood score, craving for sweets score and craving for savoury food score

  Baseline to week 24

• Change in power of food questionnaire for: food available score, food present score, food tasted score and composite score

  Baseline to week 24

• Change in blood oxygen level dependant (BOLD) response to food cues in the brain reward areas

  Baseline to week 24

Study Arms (2)

Part A

OTHER

Participants will not get any medicine during this study.

Other: No treatment given

Part B

EXPERIMENTAL

Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake period.

Drug: Cagrilintide and Semaglutide; Drug: Placebo

Interventions

No treatment given OTHER

Participants will not get any medicine during this study.

Part A

Cagrilintide and Semaglutide DRUG

Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide.

Part B

Placebo DRUG

Participants will receive subcutaneous (s.c.) injections of placebo matched to Cagrilintide and Semaglutide.

Part B

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
• Right-handed as evaluated by the Edinburgh Handedness Inventory
• Body weight less than or equal to 180 kilogram at screening
• For Part A:
• A score of 7 or less on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
• Body mass index between 18.5 and 24.9 kilogram per meter square (both inclusive) at screening
• For Part B:
• A score of 8 or more on the 16-item Disinhibition subscale of the Three Factor Eating Questionnaire
• Body mass index equal to or above 27.0 kilogram per meter square. Overweight should be due to excess adipose tissue, as judged by the investigator

You may not qualify if:

• Contraindication for magnetic resonance scanning
• For Part B:
• Glycated haemoglobin greater than or equal to 6.5 % (48 millimoles per mole) at screening
• History of type 1 or type 2 diabetes mellitus

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity

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 Reporting Office 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
• 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: February 12, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: April 7, 2025
• Study Completion: December 8, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)