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)

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Melliuts, Type 2; Overweight and/or Obesity; Obesity; Knee Osteoarthritis

Treatments: Drug: Berobenatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07915609

VESPER-OA 2 (Other Identifier)

C6491023

2026-527180-15-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 756 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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% (48 mmol/mol) and <10.0% (86 mmol/mol) for participants with T2D

Exclusion Criteria

• Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.

• For participants with T2D at Screening only:

  • 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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756 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Arm 1: Berobenatide Once Weekly

Experimental group

Description:

Berobenatide Once Weekly

Treatment:

Drug: Berobenatide

Arm 2: Berobenatide Once Weekly

Experimental group

Description:

Berobenatide Once Weekly

Treatment:

Drug: Berobenatide

Arm 3: Berobenatide Once Weekly

Experimental group

Description:

Berobenatide Once Weekly

Treatment:

Drug: Berobenatide