Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45+
SponsorKeyBioscience AG
About this trial
The goal of this clinical trial is to learn if KBP-336 works to treat pain in osteoarthritis in individuals living with obesity. It will also learn about the effects on other parameters, such as quality of life and metabolism, as well as safety of KBP-336. The main questions it aims to answer are:
* Does KBP-336 lower knee pain from osteoarthritis in individuals with obesity * Does KBP-336 lower bodyweight in the same population. Researchers will compare KBP-336 to a placebo (a look-alike substance that contains no drug) to see if KBP-336 works to pain and obesity
Participants will:
* Take KBP-336 or a placebo every week for 6 months * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the amount of medication they use in addition to KBP-336
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant is able to read and understand the language and content of the study material and provide written Informed Consent.
Willing and able to comply with study requirements and instructions
A diagnosis of OA of the target knee based on American College of Rheumatology (ACR) clinical and radiographic criteria(31), with OA symptoms (as reported by the participant) that have been present for at least 3 months prior to screening
Radiological OA grade 2 or 3 of the target knee, using the Kellgren-Lawrence method as graded by a central reader on a Fixed-Flexion X-ray obtained during screening, or on a recent (within 6 months) X-ray which fulfills the protocol specifications for reading
Disqualifiers
Partial or complete joint replacement of either knee
Target knee surgery or arthroscopy within 1 year prior to screening
Diagnosis of OA resulting from trauma within the last 5 years
Pain of the contralateral knee exceeding that of the target knee at the baseline visit, as measured by the WOMAC pain subscale
Trial design
Design model
Parallel
Treatments tested in this trial
KBP-336
DrugKBP-336 is a long acting Dual Amylin and Calcitonin Receptor agonist designed for weekly administration through subcutaneous injection.
Placebo
DrugPlacebo to match KBP-336
Treatment groups
600 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: KBP-336 Dose 1Active comparator 1 intervention
Group C: KBP-336 Dose 2Active comparator 1 intervention
Group D: KBP-336 Dose 3Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportional change in body weight from baseline to endpoint
Time frame
183 Days2
The change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale from baseline to endpoint
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Following assessment the scores are normalized.
Time frame
183 DaysSecondary outcomes
1
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness and function scales during the trial and at Day 183
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Following assessment the scores are normalized.
Time frame
183 Days2
Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183
Time frame
183 Days3
Proportion of subjects reaching ≥30 and ≥50% reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale from baseline at Day 183
Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Following assessment the scores are normalized.
Time frame
183 Days4
Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) at Day 183
The AQoL-8D consists of eight dimensions measured by 35 items with four to six levels each. Five out of eight dimensions assess the psychosocial domains of health: happiness, coping, self-worth, relationships, and mental health. The scale if from 0 - 1 and is calculated using (https://www.aqol.com.au/index.php/scoring-algorithms)
Time frame
183 DaysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov