NCT06732245

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Biomed Industries, Inc. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	NA-931	NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo
DRUG	Tirzepatide	Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)
DRUG	Tirzepatide	Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist • Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)
DRUG	NA-931	NA-931, an oral, daily • A quadruple receptor agonist
DRUG	NA-931	NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
DRUG	NA-931	NA-931 (oral daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
DRUG	NA-931 150 mg + no Tirzepatide	NA-931 150 mg + no Tirzepatide
DRUG	NA-931	NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound
DRUG	NA-931	NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound

Timeline

• Start date: 2026-08-15
• Primary completion: 2027-08-15
• Completion: 2027-12-15
• First posted: 2024-12-13
• Last updated: 2026-03-27

Locations

17 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study