Clinical trial NCT06478563: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Obesity
Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
timeFrame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Secondary outcomes:
measure: Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state
timeFrame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
measure: Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state
timeFrame: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
measure: Phase B: The area under the NNC0487-0111 plasma concentration-time curve
timeFrame: From pre-dose to after dosing on day 132
measure: Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose
timeFrame: From pre-dose to after dosing on day 132
measure: Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose
timeFrame: From pre-dose to after dosing on day 132
measure: Phase B:The terminal half-life of NNC0487-0111 after the last dose
timeFrame: From pre-dose on day 132 until completion of the end of study visit (day 153)
measure: Number of treatment emergent adverse events (TEAE)
timeFrame: From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Lincoln
state: Nebraska
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: