A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity

NCT07508020 | Recruiting Phase 1

• 3 other identifiers: NN9490-8151U1111-1319-92462025-521393-34
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

  Measured as percentage change of energy.

  From Baseline to Day 126

• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

  Measured as percentage change of energy.

  From Baseline to Day 182

• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

  Measured as percentage change of energy.

  From Baseline to Day 238

Secondary Outcomes (17)

• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126

  From Baseline to Day 126

• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182

  From Baseline to Day 182

• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238

  From Baseline to Day 238

• Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126

  From Baseline to Day 126

• Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182

  From Baseline to Day 182

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly.

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.

Drug: Placebo (matched to NNC0487-0111)

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

NNC0487-0111

Placebo (matched to NNC0487-0111) DRUG

Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Placebo

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.
• 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.
• Overweight should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• History of type 1 or type 2 diabetes mellitus.
• Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) at screening.
• Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
• 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.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

RECRUITING

MeSH Terms

Conditions

Obesity

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

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: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): January 22, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)