Osteoarthritis in the KneePhase 2NCT06833749
Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis
A Phase 2 study testing KBP-336 in people with Osteoarthritis in the Knee and Obesity, run by KeyBioscience AG at 20 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis in the Knee, Obesity
- What is being tested?
- KBP-336
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 28 Jan 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 32Show fewer
- 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
- History or presence of clinically significant neurological disease or psychiatric disorder in the opinion of the investigator
- Intra-articular injection of corticosteroids within 3 months or hyaluronic acid within 6 months of screening in the target knee or into any other major joint within 30 days prior to screening (for extended-release corticosteroid injections: within 6 months in target knee and 3 months into any other major joint).
- Systemic corticosteroid treatment for the treatment of musculoskeletal conditions of more than 14 days during the past 6 months prior to screening.
- Any pharmacological or non-pharmacological treatment primarily targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
- Treatment with medication for obesity, including GLP-1 analogues, unless the dose of use has been stable for at least six months prior to screening
- Vitamin D deficiency defined as blood 25-OH D3 concentration ≤25 nmol/L. Vitamin D supplementation and subsequent rescreening is allowed
- Presence or history of clinically significant allergies, including relevant drug hypersensitivity or allergy
- Current malignancy or treatment for malignancy within the past five years, apart from resected basal cell carcinoma, squamous skin cell carcinoma, or resected cervical atypia or carcinoma in situ, unless affecting the target knee area.
- History of alcohol or drug abuse within 5 years prior to screening, in the opinion of the Investigator.
- Use of an investigational drug within 90 days prior to screening
- For women of childbearing potential:
- Pregnancy (i.e. positive serum pregnancy test at screening) or breastfeeding
- Failure to agree to practice a highly effective method of contraception (see Appendix 2), from enrolment up to at least 3 months after the study end
- For sexually active men with a female partner of childbearing potential:
- Failure to agree to ensure that their female partners use a highly effective method of contraception (see Appendix 2) from enrolment up to at least 3 months after the study end
- Failure to agree not to donate sperm throughout the study and at least 3 months after the study end
- Unsuitable for study participation for any reason in the opinion of the Investigator.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
20 sites in 6 countries
Czechia6 sites, 6 recruiting
- Not yet recruiting
Pratia Brno, s.r.o
Brno
Principal Investigator, + 42 0732307509, simona.pappova@ccrbrno.cz
- Not yet recruiting
L.K.N. Artrocentrum
Hlučín
Principal Investigator, +420 572 551 850, arthrocentrum@email.cz
- Not yet recruiting
Medical Plus, s.r.o
Hradiště
Principal Investigator, +420 572 551 850, evadokoupil@gmail.com
- Not yet recruiting
Pratia Pardubice a.s.
Pardubice
Principal Investigator, +420 572 551 850, maca.svobodova@post.cz
- Not yet recruiting
Affidea Praha s.r.o
Prague
Principal Investigator, +420 267 090 811, rosaj@affidea-praha.cz
- Not yet recruiting
Pratia Prague, s.r.o
Prague
Principal Investigator, +42 0776807304, jan.nohejl@ccrprague.com
Poland5 sites, 5 recruiting
- Not yet recruiting
NZOZ Bif-Med. s.c.
Bytom
Principal Investigator, +48 508 270 636, hannamastalerz@wp.pl
- Not yet recruiting
Medyczne Centrum Hetmańska
Poznan
Principal Investigator, +48 61 864 20 70, piotr.leszczynski@centrum-hetmanska.pl
- Not yet recruiting
DC-MED SP z o.o.
Swidnica
Principal Investigator, +48 533 509 794, p.michalec@dc-med.pl
- Not yet recruiting
NZOZ Lecznica MAK-MED s.c.
Warsaw
Principal Investigator, +48 604 435 392, marekkrogulec@wp.pl
- Not yet recruiting
Migre Polskie Centrum Leczenia Migreny
Wroclaw
Principal Investigator, +48 694 456 511, kontakt@klinika-leczenia-bolu.pl
Denmark3 sites, 3 recruiting
- Recruiting
Sanos Clinic Nordjylland
Gandrup
Principal Investigator, MD, +45 7370 8220, cec@sanosclinic.com
- Recruiting
Sanos Clinic Herlev
Herlev
Principal Investigator, MD, +45 7370 8200, bhu@sanosclinic.com
- Recruiting
Sanos Clinic Syddanmark
Vejle
Principal Investigator, MD, +45 7370 8210, dlo@sanosclinic.com
Moldova3 sites, 3 recruiting
- Not yet recruiting
IMSP Sptalul Clinic Municipal "Sfanta Treime"
Chisinau
Principal Investigator, MD, +40 745831775, svetaagachi@yahoo.com
- Not yet recruiting
PMSI Cardiology Institute/RTL SM SRL
Chisinau
Principal Investigator, MD, +373 79 401 357, mminodora2001@yahoo.com
- Not yet recruiting
Timofei Mosneaga Republican Clinical Hospital
Chisinau
Principal Investigator, MD, +373 79 403 519, liliana9groppa@gmail.com
Romania2 sites, 2 recruiting
- Not yet recruiting
Policlinica CCBR
Bucharest
Principal Investigator, +40 021 340 1425, sorica.mustatea@policlinica-ccbr.ro
- Not yet recruiting
Quantum Medical Bucharest
Bucharest
Principal Investigator, +45 51997709, jub@nbcd.com
Hong Kong1 site, 1 recruiting
- Not yet recruiting
Hong Kong Center for Clinical Research
Hong Kong
Principal Investigator, MD, +852 3110 6699, edith.lau@hkosc.org
About this study
Official title: A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-336 As an Adjunct to Diet and Exercise in Obese Individuals with Osteoarthritis of the Knee
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
Read more
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
- Being tested
- KBP-336, Placebo
- Keywords
- Obesity, Osteoarthritis, KBP-336, Pain, Phase 2
- Medical subject headings
- Obesity, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBP-336Drug
KBP-336 is a long acting Dual Amylin and Calcitonin Receptor agonist designed for weekly administration through subcutaneous injection.
PlaceboDrug
Placebo to match KBP-336
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KBP-336 Dose 1 | Active comparator | Not described Receives: Drug: KBP-336 |
| KBP-336 Dose 2 | Active comparator | Not described Receives: Drug: KBP-336 |
| KBP-336 Dose 3 | Active comparator | Not described Receives: Drug: KBP-336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportional change in body weight from baseline to endpoint
Measured: 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.
Measured: 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
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.
Measured: 183 Days
Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183
Measured: 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
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.
Measured: 183 Days
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)
Measured: 183 Days
Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) subscore Independent living 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)
Measured: 183 Days
Change from baseline in the weekly average of daily pain using the Numerical Rating Scale (NRS) during the trial, and at Day 183
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 183 Days
Area under the curve from baseline in the weekly average of daily pain using the Numerical Rating Scale (NRS) to Day 183
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 183 Days
Change from baseline to Day 183 in waist-to-hip ratio
Measured: 183 Days
Change from baseline in whole body composition by DXA at Day 183
Measured: 183 Days
Change from baseline in bone mineral density of the lumber spine, femoral head, and total hip by DXA at Day 183
Measured: 183 Days
Change from baseline in Patient Global Assessment at Day 183
Measured: 183 Days
Outcome Measures in Rheumatology (OMERACT) - Osteoarthritis Research Society International (OARSI) responder rates at Day 183
Measured: 183 Days
Average weekly days using rescue medication
Measured: 183 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start28 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis in the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, Randomized, Placebo-controlled trial design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KeyBioscience AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833749
- Sponsor's protocol ID
- KBP-336-CD-003
- Other IDs
- 2024-517264-27-00
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-336 As an Adjunct to Diet and Exercise in Obese Individuals with Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT06833749
- Acronym / sponsor ID
- KBP-336-CD-003
- Conditions
- Osteoarthritis in the Knee, Obesity
- Keywords
- Obesity, Osteoarthritis, KBP-336, Pain, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- KeyBioscience AGIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, Randomized, Placebo-controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KBP-336KBP-336 is a long acting Dual Amylin and Calcitonin Receptor agonist designed for weekly administration through subcutaneous injection. | Drug | KBP-336 Dose 1, KBP-336 Dose 2, KBP-336 Dose 3 |
| PlaceboPlacebo to match KBP-336 | Drug | Placebo |
Primary outcome
The proportional change in body weight from baseline to endpoint
Time frame: 183 Days
The change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale from baseline to endpoint
Time frame: 183 Days
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.
13 secondary outcomes
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness and function scales during the trial and at Day 183
Time frame: 183 Days
Proportion of subjects reaching ≥5, ≥10 or ≥15% weight loss from baseline at Day 183
Time frame: 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
Time frame: 183 Days
Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) at Day 183
Time frame: 183 Days
Change from baseline in Assessment of Quality of Life 8 Dimensions (AQol 8D) subscore Independent living at Day 183
Time frame: 183 Days
Change from baseline in the weekly average of daily pain using the Numerical Rating Scale (NRS) during the trial, and at Day 183
Time frame: 183 Days
Area under the curve from baseline in the weekly average of daily pain using the Numerical Rating Scale (NRS) to Day 183
Time frame: 183 Days
Change from baseline to Day 183 in waist-to-hip ratio
Time frame: 183 Days
Change from baseline in whole body composition by DXA at Day 183
Time frame: 183 Days
Change from baseline in bone mineral density of the lumber spine, femoral head, and total hip by DXA at Day 183
Time frame: 183 Days
Change from baseline in Patient Global Assessment at Day 183
Time frame: 183 Days
Outcome Measures in Rheumatology (OMERACT) - Osteoarthritis Research Society International (OARSI) responder rates at Day 183
Time frame: 183 Days
Average weekly days using rescue medication
Time frame: 183 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KBP-336 in people with Osteoarthritis in the Knee and Obesity, run by KeyBioscience AG at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Czechia, Poland, Denmark, Moldova, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KeyBioscience AG Program Director, PhD (+41 795207086, rocco@keybioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportional change in body weight from baseline to endpoint (time frame: 183 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.