Actively Recruiting
Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis
Led by KeyBioscience AG · Updated on 2025-02-19
600
Participants Needed
20
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read and understand study materials and provide written consent
- Willing and able to follow study instructions
- Diagnosed with osteoarthritis of the target knee for at least 3 months
- Radiological osteoarthritis grade 2 or 3 in the target knee
- Age 45 years or older
- Body Mass Index of 30 kg/m2 or higher
- In good health with no significant medical issues
- Insufficient pain relief or intolerance to standard osteoarthritis treatments
- Knee pain score of 20 or higher on the WOMAC pain scale
- Willing to stop other pain medications except allowed rescue medications during the study
You will not qualify if you...
- Partial or complete knee joint replacement
- Knee surgery or arthroscopy within 1 year before screening
- Osteoarthritis from trauma in last 5 years
- More pain in opposite knee than target knee
- Planned major surgery in next 6 months
- Uncontrolled thyroid disease
- Weight loss over 5% in last 6 months
- Bariatric surgery within last 12 months
- Other conditions affecting the target knee or causing arthritis
- Active conditions affecting knee pain reporting
- High depression score (PHQ-9 63 15)
- History of gout or pseudogout likely to flare during study
- Hip dislocation or congenital hip dysplasia with joint disease
- Previous participation in related drug studies
- Significant neurological or psychiatric disorders
- Recent corticosteroid or hyaluronic acid injections in target or major joints
- Recent systemic corticosteroid use for musculoskeletal conditions
- Recent changes in osteoarthritis treatments
- Use of obesity medications unless stable for 6 months
- Vitamin D deficiency unless supplemented and re-screened
- Significant allergies or drug hypersensitivity
- Current or recent cancer treatment except some skin or cervical conditions
- History of alcohol or drug abuse in past 5 years
- Use of investigational drugs within 90 days before screening
- For women of childbearing potential: pregnancy, breastfeeding, or not agreeing to effective contraception
- For sexually active men with female partners of childbearing potential: not agreeing to contraception or sperm donation restrictions
- Any other reason investigator considers unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 20 locations
1
Pratia Brno, s.r.o
Brno, Czechia
Not Yet Recruiting
2
L.K.N. Artrocentrum
Hlučín, Czechia
Not Yet Recruiting
3
Medical Plus, s.r.o
Hradiště, Czechia
Not Yet Recruiting
4
Pratia Pardubice a.s.
Pardubice, Czechia
Not Yet Recruiting
5
Affidea Praha s.r.o
Prague, Czechia
Not Yet Recruiting
6
Pratia Prague, s.r.o
Prague, Czechia
Not Yet Recruiting
7
Sanos Clinic Nordjylland
Gandrup, Denmark
Actively Recruiting
8
Sanos Clinic Herlev
Herlev, Denmark
Actively Recruiting
9
Sanos Clinic Syddanmark
Vejle, Denmark
Actively Recruiting
10
Hong Kong Center for Clinical Research
Hong Kong, Hong Kong
Not Yet Recruiting
11
IMSP Sptalul Clinic Municipal "Sfanta Treime"
Chisinau, Moldova
Not Yet Recruiting
12
PMSI Cardiology Institute/RTL SM SRL
Chisinau, Moldova
Not Yet Recruiting
13
Timofei Mosneaga Republican Clinical Hospital
Chisinau, Moldova
Not Yet Recruiting
14
NZOZ Bif-Med. s.c.
Bytom, Poland
Not Yet Recruiting
15
Medyczne Centrum Hetmańska
Poznan, Poland
Not Yet Recruiting
16
DC-MED SP z o.o.
Swidnica, Poland
Not Yet Recruiting
17
NZOZ Lecznica MAK-MED s.c.
Warsaw, Poland
Not Yet Recruiting
18
Migre Polskie Centrum Leczenia Migreny
Wroclaw, Poland
Not Yet Recruiting
19
Policlinica CCBR
Bucharest, Romania
Not Yet Recruiting
20
Quantum Medical Bucharest
Bucharest, Romania
Not Yet Recruiting
Research Team
K
KeyBioscience AG Program Director, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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