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

Conditions

• Obesity and Overweight

Eligibility Criteria

Sex

ALL

Age

19 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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

Key Dates

Start date

Aug 15, 2026

Status verified

Dec 2025

Primary completion

Aug 15, 2027

Completion

Dec 15, 2027

Study Design

Enrollment

224 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: 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.
• Placebo Comparator: 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.
• Placebo Comparator: 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.
• Experimental: 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.
• Active Comparator: 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.
• Active Comparator: 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.
• Experimental: 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
• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

Change from baseline in body weight at 48 weeks [ Time Frame: 48 weeks ]

Central Contacts

• Lloyd Tran, PhD
  1-800-824-5135
  [email protected]
• Jennifer Thompson, MS
  1-800-824-5135
  [email protected]

Locations (8)

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