A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)

Pfizer

Summary

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. Study activities will include blood tests, knee pain assessment, physical function questionnaires and body measurements.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion 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. * History of at least 1 self-reported unsuccessful dietary effort to lose body weight. HbA1c value at Screening of: 1. \<6.5% (48 mmol/mol) for participants without T2D 2. ≥6.5%…

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)

Summary

Eligibility

Interventions

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