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

NCT ID: NCT06732245

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-12-15

Brief Summary

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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

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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

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Obesity and Overweight

Keywords

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NA-931 Obesity Biomed Industries, Inc overweight Tirzepatide Zepbound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 The extension period is then followed by a 12-week post-treatment period, during which all study treatments will be withdrawn from all arms.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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

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Placebo Comparator: Placebo

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.

Group Type PLACEBO_COMPARATOR

NA-931

Intervention Type DRUG

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

Tirzepatide (s.c. weekly)

* Glucagon-like peptide-1 (GLP-1) receptor agonist
* Other Names:

* Mounjaro
* Zepbound

Placebo + Tirzepatide 5 mg

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.

Group Type PLACEBO_COMPARATOR

NA-931

Intervention Type DRUG

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

Tirzepatide (s.c. weekly)

* Glucagon-like peptide-1 (GLP-1) receptor agonist
* Other Names:

* Mounjaro
* Zepbound

Placebo + Tirzepatide 10 mg

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.

Group Type PLACEBO_COMPARATOR

NA-931 150 mg + no Tirzepatide

Intervention Type DRUG

NA-931 150 mg + no Tirzepatide

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

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.

Group Type EXPERIMENTAL

NA-931

Intervention Type DRUG

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 60 mg + Tirzepatide 5 mg

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.

Group Type ACTIVE_COMPARATOR

NA-931

Intervention Type DRUG

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-931 120 mg + Tirzepatide 5 mg

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.

Group Type ACTIVE_COMPARATOR

NA-931

Intervention Type DRUG

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

Tirzepatide (Zepbound) placebo

NA-931 150 mg + no Tirzepatide

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

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Tirzepatide (s.c. weekly)

* Glucagon-like peptide-1 (GLP-1) receptor agonist
* Other Names:

* Mounjaro
* Zepbound NA-931 Placebo (oral, daily)

NA-931 150 mg + Tirzepatide 2.5 mg

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.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist

• Other Names:

* Mounjaro
* Zepbound

NA-931 Placebo (oral, daily)

NA-931 150 mg + Tirzepatide 5 mg

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.

Group Type ACTIVE_COMPARATOR

NA-931

Intervention Type DRUG

NA-931, an oral, daily

• A quadruple receptor agonist

Interventions

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NA-931

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

Tirzepatide (Zepbound) placebo

Intervention Type DRUG

Tirzepatide

Tirzepatide (s.c. weekly)

* Glucagon-like peptide-1 (GLP-1) receptor agonist
* Other Names:

* Mounjaro
* Zepbound NA-931 Placebo (oral, daily)

Intervention Type DRUG

Tirzepatide

Tirzepatide (s.c. weekly), a Glucagon-like peptide-1 (GLP-1) receptor agonist

• Other Names:

* Mounjaro
* Zepbound

NA-931 Placebo (oral, daily)

Intervention Type DRUG

NA-931

NA-931, an oral, daily

• A quadruple receptor agonist

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

NA-931 150 mg + no Tirzepatide

NA-931 150 mg + no Tirzepatide

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Tirzepatide placebo NA-931 Placebo NA-931 Placebo Tirzepatide Tirzepatide Tirzepatide Tirzepatide

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioneurals Ltd

UNKNOWN

Sponsor Role collaborator

Biomed Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lloyd Tran, PhD

Role: STUDY_CHAIR

Biomed Industries, Inc.

Locations

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Biomed Research Unit #90067-102

Los Angeles, California, United States

Site Status

Biomed Research Unit # 92121-103

San Diego, California, United States

Site Status

Biomed Research Unit # 94104-101

San Francisco, California, United States

Site Status

Biomed Research Unit # 33012-104

Hialeah, Florida, United States

Site Status

Biomed Research Unit # 32256-105

Jacksonville, Florida, United States

Site Status

Biomed Research Unit # 33461-106

Lake Worth, Florida, United States

Site Status

Biomed Research Unit # 10021-107

New York, New York, United States

Site Status

Biomed Research Unit # 77479-108

Sugar Land, Texas, United States

Site Status

Biomed Research Unit-NSW-2100-109

Brookvale, New South Wales, Australia

Site Status

Biomed Research Unit-NSW-2065-110

Saint Leonards,, New South Wales, Australia

Site Status

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

South Brisbane, Queensland, Australia

Site Status

Biomed Research Unit-VIC-3124-112

Camberwell, Victoria, Australia

Site Status

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

Heidelberg West, Victoria, Australia

Site Status

Biomed Research Unit-NZ-1010-114

Auckland, Auckland, New Zealand

Site Status

Biomed Research Unit-NZ-2025-115

Papatoetoe, Auckland, New Zealand

Site Status

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

Hamilton, New Zealand, New Zealand

Site Status

Biomed Research Unit-NZ- 6242-117

Newtown, Wellington Region, New Zealand

Site Status

Countries

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United States Australia New Zealand

Central Contacts

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Lloyd Tran, PhD

Role: CONTACT

Phone: 1-800-824-5135

Email: [email protected]

Jennifer Thompson, MS

Role: CONTACT

Phone: 1-800-824-5135

Email: [email protected]

Facility Contacts

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David Nguyen, PhD

Role: primary

Jennifer Thompson, MS

Role: backup

Lloyd Tran, PhD

Role: backup

Jennifer Thompson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Jennifer Thompson, MS

Role: backup

Jennifer Thompson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

Jennifer Thompson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

Jennifer Thompson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

Jennifer Thompson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

Jennifer Thomson, MS

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen

Role: primary

Lloyd Tran, PhD

Role: backup

David Nguyen, PhD

Role: primary

Lloyd Tran, PhD

Role: backup

Other Identifiers

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NA-931-200

Identifier Type: -

Identifier Source: org_study_id