A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

NCT07557953 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN9833-8421U1111-1325-88102025-524206-15
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

  Measured in percentage (%).

  From baseline (Day 2) to end of treatment (Day 127)

Secondary Outcomes (9)

• Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box

  From baseline (Day 2) to end of treatment (Day 127)

• Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box

  From baseline (Day 2) to end of treatment (Day 127)

• Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box

  From baseline (Day 2) to end of treatment (Day 127)

• Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)

  From baseline (Day 1) to end of treatment (Day 126)

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

  From baseline (Day 1) to end of treatment (Day 126)

Study Arms (2)

Cagrilintide

EXPERIMENTAL

Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.

Drug: Cagrilintide

Placebo Cagrilintide

PLACEBO COMPARATOR

Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks.

Drug: Placebo Cagrilintide

Interventions

Cagrilintide DRUG

Cagrilintide is administered subcutaneously .

Cagrilintide

Placebo Cagrilintide DRUG

Placebo Cagrilintide is administered subcutaneously.

Placebo Cagrilintide

Eligibility Criteria

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

You may qualify if:

• Male or female (sex at birth).
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be generally healthy, except for overweight or obesity, 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.

You may not qualify if:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
• Glycated haemoglobin (HbA1c) ≥ 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 at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
• Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
• Previous dosing of marketed or non-marketed amylin-based compounds.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

cagrilintide

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

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

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: April 23, 2026
• First Posted: April 30, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): April 13, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)