Clinical Trial for Obesity, Overweight and/or Obesity, Knee Osteoarthritis, Diabetes Melliuts and Type 2.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

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

Sex

Male or Female

Age

18+ years

Healthy participants

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Eligibility 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:

<6.5% (48 mmol/mol) for participants without T2D
≥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.

Study overview

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.

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Miles

0500

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4 sites found

Central Alabama Research

Birmingham, Alabama, United States, 35209

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Carolina Research Center

Shelby, North Carolina, United States, 28150

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International Research Associates LLC

Miami, Florida, United States, 33183

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Noble Clinical Research, LLC

Tucson, Arizona, United States, 85704

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Join PfizerConnect

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)

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

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)

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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