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

NCT06732245 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: NA-931-200
• Study Type: interventional
• Target: 224
• Locations: 3 countries
• Sites: 17

Brief 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

Conditions

Obesity and Overweight

Keywords

NA-931; Obesity; Biomed Industries, Inc; overweight; Tirzepatide; Zepbound

Outcome Measures

Primary Outcomes (1)

• Change from baseline in body weight at 48 weeks

  Change in total body weight will be measured from baseline to 48 weeks

  48 weeks

Secondary Outcomes (18)

• Change from baseline in waist circumference (cm) at 48 weeks

  48 weeks

• Change from baseline at 48 weeks in total body fat mass in kilograms (kg)

  48 weeks

• Change from baseline at 48 weeks in percent body fat

  48 weeks

• Change from baseline at 48 weeks in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) and trunk fat mass by dual-energy x-ray absorptiometry (DXA)

  48 weeks

• Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm

  48 weeks

Study Arms (9)

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo Comparator: Placebo to oral NA-931 120 mg daily + no Tirzepatide Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg daily at Weeks 60 and 72.

Drug: NA-931

Placebo + Tirzepatide 5 mg

PLACEBO COMPARATOR

Other: Placebo + Tirzepatide 5 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48, and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Drug: NA-931

Placebo + Tirzepatide 10 mg

PLACEBO COMPARATOR

Placebo + Tirzepatide 10 mg Participants will receive oral placebo at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 10 mg weekly per the dose escalation schedule.

Drug: Tirzepatide; Drug: NA-931 150 mg + no Tirzepatide

NA-931 60mg to NA-931 150 mg + no Tirzepatide

EXPERIMENTAL

Experimental: NA-931 60mg to NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 during the core treatment period and will switch during the extension period to receive NA-931 60 mg at Weeks 60 and 72.

Drug: NA-931

NA-931 60 mg + Tirzepatide 5 mg

ACTIVE COMPARATOR

NA-931 60 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Drug: NA-931

NA-931 120 mg + Tirzepatide 5 mg

ACTIVE COMPARATOR

NA-931 120 mg + Tirzepatide 5 mg Participants will receive oral NA-931 60 mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg weekly per the dose escalation schedule.

Drug: NA-931

NA-931 150 mg + no Tirzepatide

EXPERIMENTAL

Experimental: NA-931 150 mg + no Tirzepatide Participants will receive oral NA-931 150 mg at baseline and at Weeks 4, 12, 24, 36 and 48

Drug: Tirzepatide; Drug: NA-931 150 mg + no Tirzepatide

NA-931 150 mg + Tirzepatide 2.5 mg

ACTIVE COMPARATOR

NA-931 150 mg + Tirzepatide 2.5 mg Participants will receive oral NA-931 150 mg at baseline, and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 2.5 mg weekly per the dose escalation schedule.

Drug: Tirzepatide; Drug: NA-931

NA-931 150 mg + Tirzepatide 5 mg

ACTIVE COMPARATOR

NA-931 150 mg + Tirzepatide 5 mg Participants will receive oral NA-931 150mg at baseline and at Weeks 4, 12, and 24, 36, and 48 and s.c. Tirzepatide 5 mg per the dose escalation schedule.

Drug: NA-931

Interventions

NA-931 150 mg + no Tirzepatide DRUG

NA-931 150 mg + no Tirzepatide

NA-931 150 mg + no Tirzepatide; Placebo + Tirzepatide 10 mg

NA-931 DRUG

NA-931 (oral, daily), a quadruple receptor agonist Tirzepatide (Zepbound) placebo

Also known as: Tirzepatide placebo

NA-931 120 mg + Tirzepatide 5 mg

Tirzepatide DRUG

Tirzepatide (s.c. weekly) * Glucagon-like peptide-1 (GLP-1) receptor agonist * Other Names: * Mounjaro * Zepbound NA-931 Placebo (oral, daily)

Also known as: NA-931 Placebo

NA-931 150 mg + no Tirzepatide

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Biomed Industries, Inc.: lead
• Bioneurals Ltd: collaborator

Study Sites (17)

Biomed Research Unit #90067-102

Los Angeles, California, 90067, United States

Location

Biomed Research Unit # 92121-103

San Diego, California, 92121, United States

Location

Biomed Research Unit # 94104-101

San Francisco, California, 94104, United States

Location

Biomed Research Unit # 33012-104

Hialeah, Florida, 33012, United States

Location

Biomed Research Unit # 32256-105

Jacksonville, Florida, 32256, United States

Location

Biomed Research Unit # 33461-106

Lake Worth, Florida, 33461, United States

Location

Biomed Research Unit # 10021-107

New York, New York, 10021, United States

Location

Biomed Research Unit # 77479-108

Sugar Land, Texas, 77479, United States

Location

Biomed Research Unit-NSW-2100-109

Brookvale, New South Wales, 2100, Australia

Location

Biomed Research Unit-NSW-2065-110

Saint Leonards,, New South Wales, 2065, Australia

Location

, Australia, 4101 Biomed Research Unit-NSW-4101-111

South Brisbane, Queensland, 4101, Australia

Location

Biomed Research Unit-VIC-3124-112

Camberwell, Victoria, 3124, Australia

Location

, Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113

Heidelberg West, Victoria, 3084, Australia

Location

Biomed Research Unit-NZ-2025-115

Papatoetoe, Auckland, 2025, New Zealand

Location

Biomed Research Unit-NZ- 6242-117

Newtown, Wellington Region, 6242, New Zealand

Location

Biomed Research Unit-NZ-1010-114

Auckland, 1010, New Zealand

Location

Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116

Hamilton, 3200, New Zealand

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Lloyd Tran, PhD

  Biomed Industries, Inc.

  STUDY CHAIR

Central Study Contacts

Lloyd Tran, PhD

CONTACT

1-800-824-5135; research@biomedind.com

Jennifer Thompson, MS

CONTACT

1-800-824-5135; research@biomedind.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: With regards to NA-931 and placebo-NA-931, the participants, Investigator and Sponsor will be blinded. Due to Tirzepatide being pre-filled, packaged and labeled by manufacturer, it is not possible to blind Tirzepatide
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is designed to have three periods. The 48-week core treatment period has 9 treatment arms, with combinations of 3 Tirzepatide doses (none, 2.5 mg and 5 mg and 10 mg injectable) and 3 NA-931 doses (0, 60 mg and 150 mg oral). The core treatment period is then followed by an open-label 12-week treatment extension period during which participants originally assigned to either placebo or NA-931 60 mg will switch to NA-931 150 mg. All other treatment assignments will remain the same. The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); NZ (4); US (8)