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)

Korábbi kezelés

• Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.
• Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.
• Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.

Más betegség

• 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
• Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.

Laborértékek

• Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.

Egyéb

• For participants with T2D at Screening only:
  • Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention

• 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.
• History of at least 1 self-reported unsuccessful dietary effort to lose body weight.
  • HbA1c value at Screening of:
• <6.5% (48 mmol/mol) for participants without T2D
• ≥6.5% (48 mmol/mol) and <10.0% (86 mmol/mol) for participants with T2D