Pfizer posts MET097 obesity results; registers new Phase 3 obesity and dermatitis trials

Pfizer reported completed Phase 2b obesity data this week alongside several newly registered or not-yet-recruiting studies spanning obesity, dermatology, autoimmune disease, and oncology support.

• The Phase 2b "VESPER-1" study of once-weekly MET097 in adults with obesity or overweight is completed, with results posted. The trial is designed to test how well MET097 works to treat individuals with obesity or overweight when compared to placebo.¹ Participants assigned to MET097 received one of four different dose levels.¹ Enrollment reached 239 participants.¹ The primary outcome was percent change from baseline in body weight at Week 28.¹
• A new Phase 3 trial of once-weekly PF-08653944 (berobenatide) in Chinese adults with overweight or obesity is not yet recruiting. The purpose of the study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity.² Enrollment is estimated at 300 participants.² The primary outcome is percent change from baseline in body weight at Week 48.
• A Phase 3 study of tilrekimig in moderate-to-severe atopic dermatitis is not yet recruiting. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo, randomized based on a 2:2:1 ratio, meaning out of 1375 participants, about 550 will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo.³
• A Phase 1 study of tilrekimig co-mixed with rHuPH20 in healthy adults is recruiting. The study aims to learn how the body handles tilrekimig when given with recombinant human hyaluronidase PH20, which is approved to help some medicines be taken up by the body when they are given together as an injection under the skin.⁴ Planned enrollment is 12 participants.⁴
• A Phase 1/2 study of PF-08154225 is not yet recruiting, testing the drug in participants with lupus, rheumatoid arthritis, myositis, or systemic sclerosis. Parts 1a and 1b are seeking participants with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis and Part 2 with also Idiopathic Inflammatory Myositis (IIM) or Systemic Sclerosis (SSc).⁵ Estimated enrollment is 54 participants.⁵
• A University of Chicago-sponsored Phase 1 study, with Pfizer as collaborator, is not yet recruiting and will give tirzepatide to lung cancer patients on lorlatinib. The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, by giving patients tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement.⁶ Enrollment is estimated at 30 participants.⁶