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

NCT06833749 | Recruiting Phase 2 DMC

• 2 other identifiers: KBP-336-CD-0032024-517264-27-00
• Study Type: interventional
• Target: 600
• Locations: 6 countries
• Sites: 20

Brief Summary

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

Osteoarthritis in the Knee; Obesity

Keywords

Obesity; Osteoarthritis; KBP-336; Pain; Phase 2

Outcome Measures

Primary Outcomes (2)

• The proportional change in body weight from baseline to endpoint

  183 Days

• 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.

  183 Days

Secondary Outcomes (13)

• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness and function scales during the trial and at Day 183

  183 Days

• Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183

  183 Days

• Proportion of subjects reaching ≥30 and ≥50% reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale from baseline at Day 183

  183 Days

• Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) at Day 183

  183 Days

• Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) subscore Independent living at Day 183

  183 Days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

KBP-336 Dose 1

ACTIVE COMPARATOR

Drug: KBP-336

KBP-336 Dose 2

ACTIVE COMPARATOR

Drug: KBP-336

KBP-336 Dose 3

ACTIVE COMPARATOR

Drug: KBP-336

Interventions

KBP-336 DRUG

KBP-336 is a long acting Dual Amylin and Calcitonin Receptor agonist designed for weekly administration through subcutaneous injection.

KBP-336 Dose 1; KBP-336 Dose 2; KBP-336 Dose 3

Placebo DRUG

Placebo to match KBP-336

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age ≥ 45 years of either sex
• Body Mass Index (BMI) ≥ 30 kg/m2
• Good health, defined as no significantly relevant medical history or findings on physical examination, vital signs, ECG, and laboratory results in the opinion of the investigator.
• Intolerance or insufficient pain relief with standard of care (e.g. physiotherapy, paracetamol, local or systemic NSAID, short term opioid use, injections of hyaluronic acid, or corticosteroids) for symptomatic OA in the index knee in the opinion of the investigator.
• WOMAC pain subscale score in target knee at screening AND baseline ≥20 (0-50 scale)
• Willing to withdraw from any pain medication including, but not limited to, Opioids (including semisynthetic opioids), Non-Steroidal Anti-inflammatories (NSAIDs, with the exception of low-dose aspirin for thromboprophylaxis), COX-2 inhibitors, Topical medication, and Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs e.g. Duloxetine) and only use the allowed Rescue Medications from baseline to Visit 13/ET (maximum 4000 mg paracetamol per day)

You may not qualify if:

• 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
• Planned major surgery within the next 6 months
• Uncontrolled thyroid disease in the opinion of the Investigator based on medical history and laboratory results collected in screening
• Participant-reported weight loss \>5% of body weight within the last 6 months of the screening visit
• Bariatric surgery within the last 12 months of the screening visit
• Current comorbid condition, other than OA, affecting target knee or systemic illness known to be significantly associated with arthritis or joint pathology affecting any joint, including but not necessarily limited to endocrinopathies, inflammatory, or autoimmune disease with significant joint involvement (e.g., Rheumatoid Arthritis); Seronegative Spondyloarthropathies (e.g. Ankylosing Spondylitis, Psoriasis arthritis, Reactive arthritis)
• Conditions significantly affecting joint and bone health, in the opinion of the Investigator should be excluded (including but not limited to atrophic or hypotrophic OA, subchondral insufficiency fracture, osteonecrosis, osteoporotic fractures, excessive malalignment of the knee or severe chondrocalcinosis)
• Active comorbid condition other than OA (e.g radicular back pain, bursitis, tendinitis) significantly affecting target knee pain reporting in the opinion of the investigator.
• A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening
• History of gout, or pseudogout, with high likelihood of flare up during trial participation that would require NSAID treatment, in the opinion of the investigator
• Hip dislocation and congenital hip dysplasia with degenerative joint disease should be excluded.
• Participation in any previous DACRA/amylin study

Sponsors & Collaborators

• KeyBioscience AG: lead

Study Sites (20)

Pratia Brno, s.r.o

Brno, Czechia

NOT YET RECRUITING

L.K.N. Artrocentrum

Hlučín, Czechia

NOT YET RECRUITING

Medical Plus, s.r.o

Hradiště, Czechia

NOT YET RECRUITING

Pratia Pardubice a.s.

Pardubice, Czechia

NOT YET RECRUITING

Affidea Praha s.r.o

Prague, Czechia

NOT YET RECRUITING

Pratia Prague, s.r.o

Prague, Czechia

NOT YET RECRUITING

Sanos Clinic Nordjylland

Gandrup, Denmark

RECRUITING

Sanos Clinic Herlev

Herlev, Denmark

RECRUITING

Sanos Clinic Syddanmark

Vejle, Denmark

RECRUITING

Hong Kong Center for Clinical Research

Hong Kong, Hong Kong

NOT YET RECRUITING

IMSP Sptalul Clinic Municipal "Sfanta Treime"

Chisinau, Moldova

NOT YET RECRUITING

PMSI Cardiology Institute/RTL SM SRL

Chisinau, Moldova

NOT YET RECRUITING

Timofei Mosneaga Republican Clinical Hospital

Chisinau, Moldova

NOT YET RECRUITING

NZOZ Bif-Med. s.c.

Bytom, Poland

NOT YET RECRUITING

Medyczne Centrum Hetmańska

Poznan, Poland

NOT YET RECRUITING

DC-MED SP z o.o.

Swidnica, Poland

NOT YET RECRUITING

NZOZ Lecznica MAK-MED s.c.

Warsaw, Poland

NOT YET RECRUITING

Migre Polskie Centrum Leczenia Migreny

Wroclaw, Poland

NOT YET RECRUITING

Policlinica CCBR

Bucharest, Romania

NOT YET RECRUITING

Quantum Medical Bucharest

Bucharest, Romania

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations

Central Study Contacts

KeyBioscience AG Program Director, PhD

CONTACT

+41 795207086; rocco@keybioscience.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, Randomized, Placebo-controlled trial design.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 19, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (2); CZ (6); HK (1); MO (3); DK (3); PL (5)