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

Biomed Industries, Inc.

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

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.

Eligibility

Age range: 19–80 years
Sex: All
Healthy volunteers: No

Detailed 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 (barri…

Interventions

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

Locations (17)

Biomed Research Unit #90067-102
Los Angeles, California
research@biomedind.com 800-824-5135
Biomed Research Unit # 92121-103
San Diego, California
research@biomedind.com 800-824-5235
Biomed Research Unit # 94104-101
San Francisco, California
research@biomedind.com 800-824-5135
Biomed Research Unit # 33012-104
Hialeah, Florida
research@biomedind.com 800-824-5235
Biomed Research Unit # 32256-105
Jacksonville, Florida
research@biomedind.com 800-824-5135
Biomed Research Unit # 33461-106
Lake Worth, Florida
research@biomedind.com 800-824-5135