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

Phase 2Not Yet RecruitingNCT06732245

Biomed Industries, Inc.224 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

224

Conditions

Obesity and Overweight

Interventions

NA-931DRUG

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

TirzepatideDRUG

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

TirzepatideDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (17)

Biomed Research Unit #90067-102

Los Angeles, California, United States

Biomed Research Unit # 92121-103

San Diego, California, United States

Outcomes

Primary Outcomes

Change from baseline in body weight at 48 weeks

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

Time frame: 48 weeks

Secondary Outcomes

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

Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).

Time frame: 48 weeks

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

Fat mass will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

Time frame: 48 weeks

Change from baseline at 48 weeks in percent body fat

Percent body fat will be obtained by dual-energy x-ray absorptiometry (DXA) Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

Time frame: 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)

Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

Time frame: 48 weeks

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

Waist circumference will be measured in standing position with a non-stretchable measuring tape and to the nearest 0.1 centimeter (cm).

Time frame: 48 weeks

Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15%

Central Contacts

Lloyd Tran, PhD

CONTACT

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

Jennifer Thompson, MS

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

NA-931, an oral, daily • A quadruple receptor agonist

NA-931DRUG

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

NA-931DRUG

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

NA-931 150 mg + no TirzepatideDRUG

NA-931 150 mg + no Tirzepatide

NA-931DRUG

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

NA-931DRUG

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

Biomed Research Unit # 94104-101

San Francisco, California, United States

Biomed Research Unit # 33012-104

Hialeah, Florida, United States

Biomed Research Unit # 32256-105

Jacksonville, Florida, United States

Biomed Research Unit # 33461-106

Lake Worth, Florida, United States

Biomed Research Unit # 10021-107

New York, New York, United States

Biomed Research Unit # 77479-108

Sugar Land, Texas, United States

Biomed Research Unit-NSW-2100-109

Brookvale, New South Wales, Australia

Biomed Research Unit-NSW-2065-110

Saint Leonards,, New South Wales, Australia

...and 7 more locations

Body weight will be measured in kilograms (kg) to the nearest 0.1 kg.

Time frame: 48 weeks

Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% by Dual energy X-ray absorptiometry (DXA)

Dual energy X-ray absorptiometry (DXA) will be used to assess the changes in body composition.

Time frame: 48 weeks

Proportion of participants at 48 weeks with change in Fat mass ≥ 10% with <5% decrease (or and increase) in lean mass by Dual energy X-ray absorptiometry (DXA)

Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition.

Time frame: 48 weeks

Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)

Dual energy X-ray absorptiometry (DXA) will be used to assess changes in body composition

Time frame: 48 weeks

Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)

Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition.

Time frame: 48 weeks

Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA)

Dual-energy x-ray absorptiometry (DXA) will be used to assess changes in body composition.

Time frame: 48 weeks

Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)

Bioelectrical impedance analysis (BIA) is a widely used method for estimating body composition.

Time frame: 48 weeks

Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]

Incidence and severity of treatment emergent adverse events (TEAEs)

Time frame: 48 weeks

Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks

BMI categories: (i) Healthy weight: 18.5 kg/m2 to 24.9 kg/m2 (ii) Overweight: 25 kg/m2 to 29.9 kg/m2 (iii) Obesity class 1: 30 kg/m2 to 34.9 kg/m2 (iv) Obesity class II: 35 kg/m2 to 39.9 kg/m2 (v) Obesity class III: ≥ 40 kg/m2

Time frame: 48 weeks

Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks

Waist-to-height ratio WHtR ratio categories: \<0.5; 0.5-0.59; ≥0.6.

Time frame: 48 weeks

Change from baseline in HbA1c (mmol/mol) at 48 weeks

To assess treatment effects on glucose metabolism and HbA1c.

Time frame: 48 weeks

Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey

Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey. To assess a subject's overall health related quality of life, as well as the physical functioning score. SF- 36 scores range from 0 (worst) to 100 (best).

Time frame: 48 weeks

Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)

Change from baseline in IWQOL-Lite CT. IWQOL-Lite CT is a 20-item modified survey instrument that is used to quantitatively assess an individual's perception of how their weight affects their day- to-day life, as well as the physical function score. Scores range from 0 (worst) to 100 (best).

Time frame: 48 weeks