safety and efficacy of na-931 and tirzepatide in adults who are overweight or obese

Conditions: Obesity and Overweight

Summary: a phase 2 study to assess the efficacy of na-931 alone or in addition to tirzepatide to assess efficacy and safety in overweight or obese men and women

this phase 2 study investigates if na-931 in addition to tirzepatide can demonstrate synergic effects by enhancing efficacy and reducing adverse events including preserve/increase muscle mass in the presence of weight and/or fat mass loss.

Eligibility criteria:
inclusion criteria: * a written informed consent must be obtained before any study-related assessments are performed. * men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria: * two negative pregnancy tests (at screening and at randomization, prior to dosing) * use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of na-931/placebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of na-931/placebo oral. * body mass index (bmi) ≥ 30 or bmi ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia) * stable body weight (± 5 kg) within 90 days of screening, and body weight \<150 kg * have a history of at least one self-reported unsuccessful behavioral effort to lose body weight * able to communicate well with the investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration exclusion criteria: * • history of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to tirzepatide (zepbound® or mounjaro®) * use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations * treatment with any medication for the indication of obesity within the past 30 days before screening * diagnosis of diabetes requiring current use of any antidiabetic drug or hba1c ≥ 6.5% note: metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an sglt2 inhibitor. a diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion. * any chronic infections likely to interfere with study conduct or interpretation such as hepatitis b (hbv), hepatitis c (hcv), or human immunodeficiency virus (hiv). history of hepatitis a or hepatitis c successfully treated is not exclusionary. active covid-19 infection. * donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\> 250 ml) within 14 days prior to the first dose * any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

Keywords: na-931 obesity biomed industries, inc overweight tirzepatide zepbound