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A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Plain-language guide to NCT06559527: phase 1 non-randomized trial of Amycretin, 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06559527
- Phase
- phase 1
- Status
- completed
- Start
- 2024-08-20
- Completion (planned or actual)
- 2025-02-24
- Participants
- 42 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2; Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Amycretin.
Participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (NovoPen®4).
It had five arms (groups): Mild Renal Impairment (experimental), Moderate Renal Impairment (experimental), Severe Renal Impairment (experimental), End-Stage Renal Disease (ESRD) (experimental) and Normal Renal Function (experimental).
The registry classes the interventions as drug.
Who Took Part
42 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent. Body mass index (BMI) between 20.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Meeting the pre-defined eGFR values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area (BSA);. Mild renal impairment - 60 - 89 (mL/min). Moderate renal impairment - 30 - 59 (mL/min).
The full record lists 9 inclusion and 3 exclusion criteria; among the exclusions: any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Amycretin group and the comparison group ran side by side rather than switching.
Being open-label, the Amycretin study did not mask who received what.
It started in 2024-08-20 with completion listed for 2025-02-24.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 6 secondary outcomes, for example Number of treatment emergent adverse events (TEAEs).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Amycretin in 42 people.
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.