A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity

Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity

This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: NNC0487-0111 (formulation D); Drug: NNC0487-0111 (formulation C)

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Lincoln

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female
• Age 18-64 years (both inclusive)
• Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
• Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
• Parathyroid hormone (PTH) outside normal range at screening
• Total calcium outside normal range at screening
• Calcitonin greater than or equal to (≥) 50 pg/mL at screening
• Amylase greater than or equal to (≥) 2 times upper limit of normal
• Lipase greater than or equal to (≥) 2 times upper limit of normal
• Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase A: NNC0487-0111 (formulation D); Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks).	Drug: NNC0487-0111 (formulation D); Participants will receive NNC0487-0111 (formulation D) tablet once daily.
Active Comparator: Phase A: NNC0487-0111 (formulation C); Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks).	Drug: NNC0487-0111 (formulation C); Participants will receive NNC0487-0111 (formulation C) tablet once daily.
Experimental: Phase B: NNC0487-0111 (formulation D); Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).	Drug: NNC0487-0111 (formulation D); Participants will receive NNC0487-0111 (formulation D) tablet once daily.
Active Comparator: Phase B: NNC0487-0111 (formulation C); Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).	Drug: NNC0487-0111 (formulation C); Participants will receive NNC0487-0111 (formulation C) tablet once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state	Measured as hours*nanomoles per liter (h*nmol/L)	From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state	Measured as nanomoles per liter (nmol/L)	From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state	Measured as hours	From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Phase B: The area under the NNC0487-0111 plasma concentration-time curve	Measured as h*nmol/L	From pre-dose to after dosing on day 132
Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose	Measured as nmol/L	From pre-dose to after dosing on day 132
Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose	Measured as hours	From pre-dose to after dosing on day 132
Phase B:The terminal half-life of NNC0487-0111 after the last dose	Measured as hours	From pre-dose on day 132 until completion of the end of study visit (day 153)
Number of treatment emergent adverse events (TEAE)	Measured as number of events	From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)

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): June 27, 2024
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: NN9487-7980; U1111-1300-3720 (Other Identifier: Universal Trial Number)

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