Study of KBP-336 to Treat Knee Osteoarthritis Pain and Obesity in Adults 45 and Older

What this Trial Is About

Researchers are evaluating KBP-336, a drug designed to treat knee pain caused by osteoarthritis in people who are also living with obesity. This Phase 2 clinical trial aims to find out if KBP-336 can reduce pain and body weight compared to a placebo, while also assessing its effects on quality of life, metabolism, and safety. The study is sponsored by KeyBioscience AG and focuses on adults aged 45 years and older with diagnosed osteoarthritis of the knee and obesity. Participants in this study will receive weekly subcutaneous injections of KBP-336 or a placebo for six months. The study compares multiple dosages of KBP-336 against placebo, with participants visiting the clinic every two weeks for checkups and tests. Throughout the trial, participants will maintain a diary recording their symptoms and use of any additional pain medications allowed as rescue treatment. During the study, participants will be regularly assessed using several tools, including the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC for pain, stiffness, and function, as well as quality of life questionnaires AQol 8D. Researchers will monitor changes in body weight, pain levels, body composition, bone density, and medication use over 183 days. Safety and well-being will be closely observed through physical exams, vital signs, ECGs, and lab tests, with the total trial duration lasting about six months for each participant.

Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis