Clinical trial NCT06732245: Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity and Overweight
Keywords: NA-931
Obesity
Biomed Industries, Inc
overweight
Tirzepatide
Zepbound
Lead sponsor: Biomed Industries, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bioneurals Ltd
First posted: 2024-12-13
Enrollment: 224
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.
Primary purpose: TREATMENT

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

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.

Eligibility 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 (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

Primary outcomes:
measure: Change from baseline in body weight at 48 weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Change from baseline in waist circumference (cm) at 48 weeks
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in total body fat mass in kilograms (kg)
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in percent body fat
timeFrame: 48 weeks
measure: 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)
timeFrame: 48 weeks
measure: Proportion of participants at 48 weeks with change in waist circumference ≥ 5 cm
timeFrame: 48 weeks
measure: Proportion of participants at 48 weeks with change in Body weight ≥ 5%, ≥ 10% and ≥15%
timeFrame: 48 weeks
measure: Proportion of participants at 48 weeks with change in Fat mass ≥ 5% ≥ 10% ≥ 15% by Dual energy X-ray absorptiometry (DXA)
timeFrame: 48 weeks
measure: 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)
timeFrame: 48 weeks
measure: Percentage of weight loss due to fat mass or lean mass at 48 weeks by dual-energy x-ray absorptiometry (DXA)
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in lean mass (kg and %) and appendicular lean mass by dual-energy x-ray absorptiometry (DXA)
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in lean mass (kg) by bioelectrical impedance analysis (BIA)
timeFrame: 48 weeks
measure: Safety and tolerability measurements throughout 48 weeks by TEAEs [safety labs, vital signs]
timeFrame: 48 weeks
measure: Proportion of Participants with change from baseline in Body Mass Index (BMI) categories at 48 weeks
timeFrame: 48 weeks
measure: Proportion of Participants with change from baseline in waist-to-height ratio (WHtR ratio) categories at 48 weeks
timeFrame: 48 weeks
measure: Change from baseline in HbA1c (mmol/mol) at 48 weeks
timeFrame: 48 weeks
measure: Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey
timeFrame: 48 weeks
measure: Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Biomed Research Unit #90067-102
state: California
city: San Diego
country: United States
facility: Biomed Research Unit # 92121-103
state: California
city: San Francisco
country: United States
facility: Biomed Research Unit # 94104-101
state: California
city: Hialeah
country: United States
facility: Biomed Research Unit # 33012-104
state: Florida
city: Jacksonville
country: United States
facility: Biomed Research Unit # 32256-105
state: Florida
city: Lake Worth
country: United States
facility: Biomed Research Unit # 33461-106
state: Florida
city: New York
country: United States
facility: Biomed Research Unit # 10021-107
state: New York
city: Sugar Land
country: United States
facility: Biomed Research Unit # 77479-108
state: Texas
city: Brookvale
country: Australia
facility: Biomed Research Unit-NSW-2100-109
state: New South Wales
city: Saint Leonards,
country: Australia
facility: Biomed Research Unit-NSW-2065-110
state: New South Wales
city: South Brisbane,
country: Australia
facility: , Australia, 4101 Biomed Research Unit-NSW-4101-111
state: Queensland
city: Camberwell,
country: Australia
facility: Biomed Research Unit-VIC-3124-112
state: Victoria
city: Heidelberg West
country: Australia
facility: , Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113
state: Victoria
city: Papatoetoe,
country: New Zealand
facility: Biomed Research Unit-NZ-2025-115
state: Auckland
city: Newtown
country: New Zealand
facility: Biomed Research Unit-NZ- 6242-117
state: Wellington
city: Auckland
country: New Zealand
facility: Biomed Research Unit-NZ-1010-114
city: Hamilton
country: New Zealand
facility: Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116
Study officials:
affiliation: Biomed Industries, Inc.
name: Lloyd Tran, PhD
role: STUDY_CHAIR
References: