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

ConditionObesity and Overweight
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorBiomed Industries, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A written informed consent must be obtained before any study-related assessments are performed.

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)

Disqualifiers

• 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.

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

224 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Placebo Comparator: PlaceboPlacebo comparator 1 intervention
Group B: Placebo + Tirzepatide 5 mgPlacebo comparator 1 intervention
Group C: Placebo + Tirzepatide 10 mgPlacebo comparator 2 interventions
Group D: NA-931 60mg to NA-931 150 mg + no TirzepatideExperimental treatment 1 intervention
Group E: NA-931 60 mg + Tirzepatide 5 mgActive comparator 1 intervention
Group F: NA-931 120 mg + Tirzepatide 5 mgActive comparator 1 intervention
Group G: NA-931 150 mg + no TirzepatideExperimental treatment 2 interventions
Group H: NA-931 150 mg + Tirzepatide 2.5 mgActive comparator 2 interventions
Group I: NA-931 150 mg + Tirzepatide 5 mgActive comparator 1 intervention

Trial outcomes

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

Time frame
48 weeks

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biomed Industries, Inc.

Lead sponsor

Bioneurals Ltd

Collaborator

Source ClinicalTrials.gov

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