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A Research Study on How NNC0487-0111, a New Medicine, Works in Chinese Participants After 10 Days of Oral Dosing
Plain-language guide to NCT06820476: phase 1 randomized trial of Amycretin, 29 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06820476
- Phase
- phase 1
- Status
- completed
- Start
- 2025-02-09
- Completion (planned or actual)
- 2025-05-14
- Participants
- 29 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Overweight; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Amycretin.
The study is testing a new study medicine called NNC0487-0111 for weight control in Chinese people with Body mass index (BMI) greater than or equal to (\>=) 24 kilogram per square meter (kg/m\^2).
Participants will either get NNC0487-0111 or placebo.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 29 actual participants took part.
It was open to men only aged from 18 years up to 55 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male Chinese participants, age 18-55 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m\^2)(both inclusive), with a body weight greater than or equal to (\>=) 65.0 kilogram (kg), at screening. Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Amycretin group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
As a double-blind Amycretin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2025-02-09 with completion listed for 2025-05-14.
It ran at 2 sites in China (2).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAEs) (time frame: From first NNC0487-0111 administration (Day 1) to completion of the end-of-study visit (Day 31)).
It also tracked 5 secondary outcomes, for example Change in bodyweight and Change in fasting plasma glucose.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Amycretin in 29 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Amycretin compound page, all human trials.
Our Notes on the Compound
Amycretin: A single molecule that activates both GLP-1 and amylin receptors, tested by injection and as a tablet in early obesity trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.