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

What Was Tested

This registered phase 2 trial tested Tirzepatide.

It had nine arms (groups): Placebo Comparator: Placebo (placebo comparator), one (placebo comparator), one (placebo comparator), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

224 planned participants were the target.

It was open to people of any sex aged from 19 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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:. 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.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: • history of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to tirzepatide (zepbound® or mounjaro®); treatment with any medication for the indication of obesity within the past 30 days before screening.

How the Study Was Run

Design: randomized, factorial and double-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-08-15 with completion listed for 2027-08-15.

It ran at 17 sites in United States (8), Australia (5) and New Zealand (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline in body weight at 48 weeks (time frame: 48 weeks).

It also tracked 18 secondary outcomes, for example Change from baseline in waist circumference (cm) at 48 weeks, Change from baseline at 48 weeks in total body fat mass in kilograms (kg), Change from baseline at 48 weeks in percent body fat, Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm, Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA) and Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 224 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.