Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese

Launched by BIOMED INDUSTRIES, INC. · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of two treatments, NA-931 and Tirzepatide, in adults who are overweight or obese. The goal is to see if these treatments can help people lose weight and improve their health. The study will include both men and women aged 18 to 80 years who meet certain criteria, such as having a body mass index (BMI) of 30 or higher, or 27 or higher with related health issues like high blood pressure or sleep apnea. Participants should also have tried to lose weight through diet and exercise in the past without success.

If you decide to participate, you will need to provide written consent before starting. The trial will involve regular visits to the clinic for assessments, and you’ll need to follow specific diet and activity plans throughout the study. It’s important to note that certain conditions, such as having diabetes that requires medication, or a history of allergic reactions to similar drugs, may prevent you from participating. This trial is not yet recruiting participants, but if you're interested, keep an eye out for updates on how to join.

Gender

ALL

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