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

Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: NNC0487-0111; Drug: Placebo (matched to NNC0487-0111)

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Recruiting
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0487-0111; Participants will be randomized to receive 1 of the different dose levels of NNC0487-0111 subcutaneously once weekly.	Drug: NNC0487-0111; NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
Placebo Comparator: Placebo; Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly.	Drug: Placebo (matched to NNC0487-0111); Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126	Measured as kilojoules (kJ).	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	Measured as kJ.	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	Measured as kJ.	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	Measured as grams.	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	Measured as grams.	From Baseline to Day 182
Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238	Measured as grams.	From Baseline to Day 238
Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378	Measured as percentage change of energy.	From Baseline to Day 378
Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378	Measured as kJ.	From Baseline to Day 378
Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378	Measured as grams.	From Baseline to Day 378
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126	Measured as kJ.	From Baseline to Day 126
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182	Measured as kJ.	From Baseline to Day 182
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238	Measured as kJ.	From Baseline to Day 238
Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 378	Measured as kJ.	From Baseline to Day 378
Relative change from Day 19 in body weight to Day 131	Measured as percentage change of body weight.	From Day 19 to Day 131
Relative change from Day 19 in body weight to Day 187	Measured as percentage change of body weight.	From Day 19 to Day 187
Relative change from Day 19 in body weight to Day 243	Measured as percentage change of body weight.	From Day 19 to Day 243
Relative change from Day 19 in body weight to Day 383	Measured as percentage change of body weight.	From Day 19 to Day 383

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2026
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): January 22, 2028

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: NN9490-8151; U1111-1319-9246 (Other Identifier: World Health Organization (WHO)); 2025-521393-34 (Other Identifier: European Medicines Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No