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

Phase 2

Waitlist Available

Research Sponsored by Biomed Industries, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks

Awards & highlights

No Placebo-Only Group

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

Eligible Conditions

Obesity

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in body weight at 48 weeks

Secondary study objectives

Change from Baseline at 48 weeks in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite)

Change from baseline at 48 weeks in Quality of Life Short Form 36 (SF-36) survey

Change from baseline at 48 weeks in fat mass (kg and %) by bioelectrical impedance analysis (BIA)

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: NA-931 60mg to NA-931 150 mg + no TirzepatideExperimental Treatment1 Intervention

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 II: NA-931 150 mg + no TirzepatideExperimental Treatment1 Intervention

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 III: NA-931 150 mg + Tirzepatide 2.5 mgActive Control1 Intervention

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 IV: NA-931 60 mg + Tirzepatide 5 mgActive Control1 Intervention

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 V: NA-931 120 mg + Tirzepatide 5 mgActive Control1 Intervention

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 VI: NA-931 150 mg + Tirzepatide 5 mgActive Control1 Intervention

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 VII: Placebo Comparator: PlaceboPlacebo Group1 Intervention

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 VIII: Placebo + Tirzepatide 5 mgPlacebo Group1 Intervention

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 IX: Placebo + Tirzepatide 10 mgPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NA-931

2024

Completed Phase 1

~80

0 / 7Eligibility criteria met