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Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes
Plain-language guide to NCT07535307: phase 1 randomized trial of Amycretin, 80 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07535307
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2026-04-10
- Completion (planned or actual)
- 2027-11-11
- Participants
- 80 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Amycretin.
The purpose of this clinical study is to find out how NNC0487-0111 affects, how the body uses insulin (a hormone that helps the body control blood sugar) and how well the pancreas works in people living with type 2 diabetes.
There are 2 study treatments.
Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it).
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
80 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female. Age 18-75 years (both inclusive) at the time of signing the informed consent. Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Because people in this Amycretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Amycretin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Amycretin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2026-04-10 with completion listed for 2027-11-11.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC) (time frame: Baseline to week 40).
It also tracked 11 secondary outcomes, for example Change in M-value in HEC, normalised by lean body mass, Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC), Change in second-phase ISR (ISR20-120 min) in HGC, Change in total ISR (ISR0-120 min) in HGC, Change in ISR at fixed glucose concentration (ISRg) in HGC and Change in total insulin response [total area under curve (AUC0-120) min] in HGC.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Amycretin in 80 people.
It is still recruiting; 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.