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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 133
Last updated 2025-08-11
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
Interventions
- DRUG
-
NNC0487-0111 (formulation D)
Participants will receive NNC0487-0111 (formulation D) tablet once daily.
- DRUG
-
NNC0487-0111 (formulation C)
Participants will receive NNC0487-0111 (formulation C) tablet once daily.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Transparency (dept. 2834) · Novo Nordisk A/S
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-27
- Primary Completion
- 2025-06-05
- Completion
- 2025-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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