Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 19 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase 2 study tests how well NA-931 works and how safe it is, alone or with tirzepatide. It is for adults ages 18 to 80 who have obesity, or who are overweight and have a weight-related health problem.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form before any study tests.
- Be 18 to 80 years old.
- Have a BMI of 30 or higher, or 27 or higher with a weight-related health problem, such as high blood pressure or sleep apnea. BMI is a measure of weight compared with height.
- Weigh less than 150 kg (about 331 pounds), with no weight change greater than 5 kg (about 11 pounds) in the 90 days before screening.
- Have tried at least once to lose weight by changing habits, without success.
- Be able to communicate with the study doctor, follow study rules, and follow the study's diet and activity plans.
- Women who can become pregnant must have two negative pregnancy tests: one at screening and one before starting treatment.
- Women who can become pregnant must use an IUD (a birth control device placed in the womb) from at least 3 months before the baseline visit until at least 4 months after the last NA-931 or placebo dose. They must also use a barrier birth control method from screening through that same end date.
Who can't join
- Have a known allergy to monoclonal antibody drugs (a type of medicine made from proteins), or a medical reason not to take tirzepatide.
- Use another study drug at enrollment or too recently before enrollment: within 30 days or five times the time it takes the drug level to drop by half, whichever is longer. Local rules may require more time.
- Have taken medicine to treat obesity within 30 days before screening.
- Have diabetes that currently needs medicine, or an HbA1c of 6.5% or higher (a test of average blood sugar). Metabolic syndrome is allowed, even if treated with blood sugar medicine. Prediabetes managed only with diet and exercise is also allowed.
- Have a long-term infection that could affect the study, such as hepatitis B, hepatitis C, or HIV, or have active COVID-19. Past hepatitis A or successfully treated hepatitis C does not rule you out.
- Have donated or lost 400 mL or more of blood within 8 weeks before the first dose, or donated more than 250 mL of plasma within 14 days. Local rules may require a longer wait after blood loss or donation.
- Have another condition, or be unwilling or unable to follow study rules, that the study doctor thinks could put your safety or participation at risk.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (8)
CA
- Biomed Research Unit #90067-102 · Los Angeles, CA 90067David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in Los Angeles
- Biomed Research Unit # 92121-103 · San Diego, CA 92121David Nguyen, PhD · Study contact · 800-824-5235 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5235 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in San Diego
- Biomed Research Unit # 94104-101 · San Francisco, CA 94104David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in San Francisco
FL
- Biomed Research Unit # 33012-104 · Hialeah, FL 33012David Nguyen, PhD · Study contact · 800-824-5235 · research@biomedind.comJennifer Thompson, MS · Study contactDavid Nguyen, PhD · Principal investigatorMore trials in Hialeah
- Biomed Research Unit # 32256-105 · Jacksonville, FL 32256David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in Jacksonville
- Biomed Research Unit # 33461-106 · Lake Worth, FL 33461David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · esearch@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in Lake Worth
NY
- Biomed Research Unit # 10021-107 · New York, NY 10021David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in New York
TX
- Biomed Research Unit # 77479-108 · Sugar Land, TX 77479David Nguyen, PhD · Study contact · 800-824-5135 · research@biomedind.comJennifer Thompson, MS · Study contact · 1-800-824-5135 · research@biomedind.comDavid Nguyen, PhD · Principal investigatorMore trials in Sugar Land