NA-931 and Tirzepatide for Obesity

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Biomed Industries, Inc.

Prior Safety Data

Trial Summary

What is the purpose of 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 is for overweight or obese adults. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

I am between 18 and 80 years old and, if capable of becoming pregnant, have had two negative pregnancy tests and will use contraception as directed.

My weight has been stable and is under 150 kg.

Exclusion Criteria

I am allergic to some monoclonal antibody drugs or cannot take Tirzepatide.

I do not have chronic infections like HBV, HCV, HIV, or active COVID-19.

I am currently taking medication for diabetes or my HbA1c level is 6.5% or higher.

Treatment Details

The study is testing the effectiveness and safety of a drug called NA-931 alone, and in combination with another drug named Tirzepatide, in managing weight for overweight or obese individuals.

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 Treatment2 Interventions

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 Control2 Interventions

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 Group2 Interventions

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 Group2 Interventions

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.