Trial intelligence / Profile preview

NNC0487-0111 in Overweight/Obesity and Knee Osteoarthritis

NCT07481630Phase 3

Key facts

Status
Recruiting
Start
Apr 2026
Primary completion
Aug 2028
Countries
10
Modality
Peptides, Small Molecules
Conditions
obesityknee osteoarthritis (OA)
01

Overview

Phase 3, randomised, double-blind trial of amycretin in obesity and knee osteoarthritis (OA) (3 arms), sponsored by Novo Nordisk. Primary endpoints: Relative change in body weight at 80 weeks and Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) pain score at 80 weeks. Started Apr 2026; status: recruiting.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • NNC0487-0111 dose level 1

    NNC0487-0111 dose level 1 subcutaneously once weekly

  • NNC0487-0111 dose level 2

    NNC0487-0111 dose level 2 subcutaneously once weekly

  • Placebo

    Placebo matched to NNC0487-0111 subcutaneously once weekly

03

Who it enrols

Participants must have overweight or obesity, clinical diagnosis of knee osteoarthritis with radiographic changes (KL grades 2-3), and symptomatic knee OA. Excludes patients with history of type 1 or type 2 diabetes.

04

Endpoints

Primary

  • Relative change in body weight

  • Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) pain score

Secondary

  • Change in WOMAC physical function score

  • Change in SF-36v2 Health Survey Acute physical functioning score

  • Change in body weight

  • Change in body mass index

  • Change in WOMAC stiffness score

  • Change in WOMAC total score

  • Change in waist circumference

  • Change in systolic blood pressure

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