A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JM)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JM)
The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition in which a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some participants in this study may also have type 2 diabetes, a condition in which the body does not use insulin properly, causing blood sugar levels to become too high.
This study is seeking participants in Japan who:
About 197 adults will take part in this study. Participants will be randomly assigned to receive either berobenatide or a placebo. A placebo looks like the study medicine but does not contain any active medicine.
Berobenatide or placebo will be given as an injection under the skin of the abdomen (belly area). The study will compare the experiences of people receiving berobenatide with those receiving placebo to determine whether berobenatide can help people lose weight. The study will also assess the safety of berobenatide and its effects on body weight and other health measures.
People will take part in this study for about 21 months. During this time, they will have about 16 study visits at the site. They will also have 2 study visits over the phone.
Inclusion Criteria:
Exclusion Criteria:
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Kasuya-gun, Fukuoka 811-2310, Japan
Chuo-ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 104-0031, Japan
Nerima-ku, Tokyo 177-0051, Japan
Shinjuku-ku, Tokyo 160-0008, Japan
Shinjuku-ku, Tokyo 169-0072, Japan
Toshima-ku, Tokyo 171-0021, Japan