About this trial
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
Eligibility criteria
Qualifiers
A written informed consent must be obtained before any study-related assessments are performed.
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)
Disqualifiers
• 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.
Trial design
Treatments tested in this trial
- NA-931
- Tirzepatide
- Tirzepatide
- NA-931
- NA-931
- NA-931
- NA-931 150 mg + no Tirzepatide
- NA-931
- NA-931
Treatment groups
9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Biomed Industries, Inc.
Lead sponsor
Bioneurals Ltd
Collaborator