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AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Plain-language guide to NCT07509307: phase 3 randomized trial of Amycretin, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07509307
Phase
phase 3
Status
recruiting participants
Start
2026-04-20
Completion (planned or actual)
2028-08-14
Participants
400 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity; Overweight; Osteoarthritis, Knee
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Amycretin.

This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo.

There are 2 study treatments in this study taken as injections under the skin once a week.

Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it).

It had two arms (groups): NNC0487-0111 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

400 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 at birth). Age 18 years or above at the time of signing the informed consent.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records; treatment with glucagon-like-peptide-1 (glp-1) receptor agonists (ra), dual glp-1/gastric inhibitory peptide (gip) ras (or any other glp-1 based treatment), or amylin analogues before screening; any joint prosthesis or joint replacement in target knee.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Amycretin and who got the comparison, which limits bias.

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 2026-04-20 with completion listed for 2028-08-14.

It ran at 81 sites in United States (19), Spain (11), Poland (9), Greece (7), Italy (7) and Turkey (Türkiye) (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Relative change in body weight (time frame: From baseline (week 0) to week 80). Change in Western Ontario and McMaster Universities Osteoarthritis Index Numerical Rating Scale (NRS) 3.1 (24-hour) (WOMAC) pain score (time frame: From baseline (week 0) to week 80).

It also tracked 27 secondary outcomes, for example Change in WOMAC physical function score, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight, Change in body mass index (BMI), Change in WOMAC stiffness score and Change in WOMAC total score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amycretin in 400 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.