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

NCT06478563 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9487-7980U1111-1300-3720
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state

  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

  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

  From pre-dose to after dosing on day 132

• Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose

  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

  From pre-dose to after dosing on day 132

Study Arms (4)

Phase A: NNC0487-0111 (formulation D)

EXPERIMENTAL

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)

Phase A: NNC0487-0111 (formulation C)

ACTIVE COMPARATOR

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)

Phase B: NNC0487-0111 (formulation D)

EXPERIMENTAL

Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).

Drug: NNC0487-0111 (formulation D)

Phase B: NNC0487-0111 (formulation C)

ACTIVE COMPARATOR

Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).

Drug: NNC0487-0111 (formulation C)

Interventions

NNC0487-0111 (formulation D) DRUG

Participants will receive NNC0487-0111 (formulation D) tablet once daily.

Phase A: NNC0487-0111 (formulation D); Phase B: NNC0487-0111 (formulation D)

NNC0487-0111 (formulation C) DRUG

Participants will receive NNC0487-0111 (formulation C) tablet once daily.

Phase A: NNC0487-0111 (formulation C); Phase B: NNC0487-0111 (formulation C)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Celerion, Lincoln

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blinded to the investigator (to the formulation).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: June 27, 2024
• Primary Completion: June 5, 2025
• Study Completion: July 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)