Obesity study: Berobenatide
Official title A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
ClinicalTrials.gov ID: NCT07915609
What this study is testing
What is Berobenatide?
Berobenatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity.
Also referred to as MET097, PF-08653944.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity with and without type 2 diabetes. The study will last 52 weeks and compare the effects of berobenatide compared to placebo on knee pain, physical function, and body weight.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults 18 years of age or older, or the minimum age of consent according to local regulations.
- Body mass index of at least 27 kg/m² at Screening.
- Currently meets American College of Rheumatology (ACR) Criteria for knee OA.
- Pain due to knee OA.
- Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.
You likely can't join if
- Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
- Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention
- Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.
- Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- Significant active or unstable psychiatric disorder.
- Condition or knee disorder that could confound assessment of target-knee pain
See the full eligibility criteria
- Adults 18 years of age or older, or the minimum age of consent according to local regulations.
- Body mass index of at least 27 kg/m² at Screening.
- Currently meets American College of Rheumatology (ACR) Criteria for knee OA.
- Pain due to knee OA.
- Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.
- Willingness to complete the required analgesic washout.
- \<6.5% (48 mmol/mol) for participants without T2D
- ≥6.5% (48 mmol/mol) and \<10.0% (86 mmol/mol) for participants with T2D
- Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
- Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention
- Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.
- Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
- Significant active or unstable psychiatric disorder.
- Condition or knee disorder that could confound assessment of target-knee pain
- Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.
- Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.
- Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.
- Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.