NCT06478563·Phase 1·INTERVENTIONAL

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

Amycretin Weight loss Completed

Status

Completed

Phase

Phase 1

Enrollment

133

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

First posted
Jun 27, 2024
Study start
Jun 27, 2024
Primary completion
Jun 5, 2025
Study completion
Jul 1, 2025
Results posted
Not reported
Registry updated
Aug 11, 2025

Outcomes

What the study measures.

Primary outcomes

Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state

Time frame · From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Measured as hours\*nanomoles per liter (h\*nmol/L)

Secondary outcomes

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

Time frame · From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Measured as nanomoles per liter (nmol/L)

Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state

Time frame · From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126

Measured as hours

Phase B: The area under the NNC0487-0111 plasma concentration-time curve

Time frame · From pre-dose to after dosing on day 132

Measured as h\*nmol/L

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

Time frame · From pre-dose to after dosing on day 132

Measured as nmol/L

Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose

Time frame · From pre-dose to after dosing on day 132

Measured as hours

Phase B:The terminal half-life of NNC0487-0111 after the last dose

Time frame · From pre-dose on day 132 until completion of the end of study visit (day 153)

Measured as hours

Number of treatment emergent adverse events (TEAE)

Time frame · From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153)

Measured as number of events

Eligibility

Who can take part.

Minimum age: 18 Years
Maximum age: 64 Years
Sex: ALL
Healthy volunteers: No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Celerion, Lincoln

Lincoln, Nebraska, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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