PF-08653944
DrugBy Subcutaneous Injection
Other names: MET097
NCT Number: NCT07400653
The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.
The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.
About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.
People will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 3
CEDIC, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
--Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
Exclusion criteria
By Subcutaneous Injection
Other names: MET097
By Subcutaneous Injection
Time frame: Baseline, Week 64
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 84
Time frame: Baseline, Week 64 and 84
Time frame: Week 64 and Week 84
Time frame: Week 64 and Week 84
Time frame: Week 64 and Week 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Baseline, Week 64 and 84
Time frame: Week 84
Time frame: Week 84
Time frame: Week 84
Time frame: Week 84
Time frame: Week 84
Time frame: Week 84
Pfizer
Industry
EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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