Recruiting
Phase 3

Berobenatide

Sponsor:

Pfizer

Code:

NCT07915609

Conditions

Obesity

Overweight and/or Obesity

Knee Osteoarthritis

Diabetes Melliuts, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Berobenatide

Placebo

Study Details

Brief 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.

Conditions

Obesity

Overweight and/or Obesity

Knee Osteoarthritis

Diabetes Melliuts, Type 2

Study ID

NCT07915609

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Aug 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

756 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo

experimental: Arm 1: Berobenatide Once Weekly

Berobenatide Once Weekly

experimental: Arm 2: Berobenatide Once Weekly

Berobenatide Once Weekly

experimental: Arm 3: Berobenatide Once Weekly

Berobenatide Once Weekly

Interventions

Berobenatide

Subcutaneous Injection

Placebo

Subcutaneous Injection

Primary outcome measure

  • Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score [ Time Frame: Baseline and Week 52 ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Central Alabama Research

Recruiting

Birmingham, Alabama, United States, 35209

More Information

Sponsor

Pfizer

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

Keywords

  • Knee Pain, Osteoarthritis, Weight Management
  • Knee Osteoarthritis
  • Overweight
  • Obesity
  • Type 2 diabetes
  • Diabetes
  • GLP1
  • GLP1 RA
  • WOMAC
  • Knee pain
  • Osteoarthritis
  • Weight Management
  • VESPER

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Pfizer on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.