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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

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Knee Osteoarthritis (AMAZE 6)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "There are 2 study treatments in this study taken as injections under the skin once a week."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NNC0487-0111 is safe and helps people with excess body weight and knee arthritis lose weight and have less pain. Participants are assigned by chance to get the study medicine or a placebo, which has no active medicine. Both are given as a shot under the skin once a week.

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). Which treatment participants get is decided by chance.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have knee osteoarthritis (arthritis from joint wear) confirmed by a doctor and an X-ray showing grade 2 to 4 changes.
  • Have pain in the study knee that started more than 90 days before screening, with pain on more than 15 of the past 30 days. The study knee is the more painful knee, or the knee on your dominant leg if pain is equal.
  • Be willing to stop pain medicines for 72 hours before visits with a knee pain questionnaire. Acetaminophen, up to 4 grams a day, is allowed for pain relief until 24 hours before those visits.

Who can't join

  • Have an HbA1c blood test result of 6.5% or higher at screening. This test measures average blood sugar.
  • Have a history of type 1 or type 2 diabetes.
  • Have used GLP-1-based medicines, including combined GLP-1/GIP medicines, or amylin-like medicines before screening. These are types of medicines used for blood sugar or weight control.
  • Have an artificial joint or joint replacement in the study knee.
  • Have had keyhole surgery or an injection into the study knee within 90 days before screening.
  • Have another joint disease in the study knee, such as gout or pseudogout, which cause crystals to build up in the joint.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Male or female (sex at birth) * Age 18 years or above at the time of signing the informed consent * Clinical diagnosis of knee osteoarthritis (OA) (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence \[KL\] grades 2 to 4 as per central reading) in target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg * Symptomatic knee OA with first appearance of pain in the target knee \> 90 days prior to screening and pain in the target knee for \> 15 days over the prior 30 days * Willingness to complete a 72-hour washout period of analgesics before all visits involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 grams (g)/day is allowed as rescue medication up until 24 hours before those visits) Key Exclusion Criteria: * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening * 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 * Arthroscopy or injections into target knee within the last 90 days prior to screening * Any other joint disease in target knee including gout and pseudogout

Study sites (19)

CA

CT

FL

IL

KY

MI

MO

NC

NY

OR

TX

VA

WA