Clinical trial

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

Opening soon · Phase 2 · 3 countries · Registry ID NCT06732245

Opening soonPhase 2Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age19 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity and Overweight

Full registry 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

Treatments and study arms

NA-931

Drug

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

Tirzepatide

Drug

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

Tirzepatide

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

Drug

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

NA-931

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

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-931 150 mg + no Tirzepatide

Drug

NA-931 150 mg + no Tirzepatide

NA-931

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

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

Primary outcomes

Change from baseline in body weight at 48 weeks48 weeks

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

Study locations

17 locations were listed when this page was built. The first 40 are shown.

Biomed Research Unit-NSW-2100-109🇦🇺 Brookvale, New South Wales, Australia
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit-VIC-3124-112🇦🇺 Camberwell, Victoria, Australia
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
, Victoria, Australia, 3084 Biomed Research Unit-VIC-3084-113🇦🇺 Heidelberg West, Victoria, Australia
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit-NSW-2065-110🇦🇺 Saint Leonards,, New South Wales, Australia
David Nguyen, PhDContact
Jennifer ThompsonContact
David Nguyen, PhDPrincipal Investigator
, Australia, 4101 Biomed Research Unit-NSW-4101-111🇦🇺 South Brisbane, Queensland, Australia
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit-NZ-1010-114🇳🇿 Auckland, New Zealand
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Hamilton, New Zealand, 3200 Biomed Research Unit-NZ-3200-116🇳🇿 Hamilton, New Zealand
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit-NZ- 6242-117🇳🇿 Newtown, Wellington Region, New Zealand
David Nguyen, PhDContact
Jennifer ThompsonContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit-NZ-2025-115🇳🇿 Papatoetoe, Auckland, New Zealand
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 33012-104🇺🇸 Hialeah, Florida, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 32256-105🇺🇸 Jacksonville, Florida, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 33461-106🇺🇸 Lake Worth, Florida, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit #90067-102🇺🇸 Los Angeles, California, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 10021-107🇺🇸 New York, New York, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 92121-103🇺🇸 San Diego, California, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 94104-101🇺🇸 San Francisco, California, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator
Biomed Research Unit # 77479-108🇺🇸 Sugar Land, Texas, United States
David Nguyen, PhDContact
Jennifer Thompson, MSContact
David Nguyen, PhDPrincipal Investigator