A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Amycretin.

NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans.

Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo.

It had 11 arms (groups): Placebo subcutaneous (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

Placebo for subcutaneous treatment.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 448 actual participants took part.

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, aged 18-75 years (both inclusive) at the time of signing the informed consent. Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening. Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2. Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: known hypoglycaemic unawareness as indicated by the investigator according to clarke's questionnaire question.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Amycretin group and the comparison group should start out alike.

The Amycretin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Amycretin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-08-07 with completion listed for 2025-10-01.

It ran at 137 sites in United States (39), Poland (14), Bulgaria (12), Japan (12), Croatia (10) and Romania (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: From baseline (week 0) to end of treatment (week 36)).

It also tracked 17 secondary outcomes, for example Relative change in body weight, Change in body weight, Change in fasting plasma glucose (FPG), Change in body mass index (BMI), Change in waist circumference and Change in systolic blood pressure (SBP).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amycretin in 448 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.