A Research Study to See How NNC0487-0111 Affects the Body's Energy Use After a Weight Loss in Adults Living With Overweight or Obesity, Compared to a Low-calorie Diet or Placebo

What Was Tested

The trial (phase 1) is built around Amycretin for fat loss, obesity & body recomposition.

The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity or overweight following weight loss.

This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).

It had three arms (groups): NNC0487-0111 (experimental), Placebo (placebo comparator) and Low Energy Diet (LED) (other).

Participants will receive once weekly subcutaneous injection of NNC0487-0111.

Participants will receive once weekly subcutaneous injection of placebo matched to NNC0487-0111.

The registry classes the interventions as behavioral and drug.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female (sex assigned at birth, inclusive of all gender identities). Age 18 years or older at the time of signing the informed consent.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: exposure to an investigational medicinal product within 30 days; any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.

How the Study Was Run

Design: 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.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Amycretin.

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

It started in 2026-08-03 with completion listed for 2028-09-18.

It ran at 2 sites in Denmark (1) and Netherlands (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in sleeping metabolic rate (SMR) (time frame: Baseline (week 0) to week 12-26).

It also tracked 4 secondary outcomes, for example Change in 24-hour energy expenditure (EE), Change in basal metabolic rate (BMR), Change in resting metabolic rate (RMR) and Change in diet-induced thermogenesis (DIT).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Amycretin in 120 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amycretin compound page, Fat loss, obesity & body recomposition research.