224 Participants Needed

NA-931 and Tirzepatide for Obesity

Recruiting at 16 trial locations
JT
LT
Overseen ByLloyd Tran, PhD
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication specifically for obesity within 30 days before screening. If you are taking medication for diabetes, you may need to stop if it is not metformin or an SGLT2 inhibitor, as these are allowed for metabolic syndrome.

Is tirzepatide safe for humans?

Tirzepatide has been studied for type 2 diabetes and shows a safety profile similar to other medications in its class, with common side effects like nausea, vomiting, diarrhea, and constipation, especially at higher doses. It has been associated with a reduction in cardiovascular events, and no increased risk of major cardiovascular issues was found in studies.12345

How is the drug NA-931 and Tirzepatide unique for treating obesity?

Tirzepatide is unique because it is a dual-action drug that targets both the GIP and GLP-1 receptors, which helps with significant weight loss and improves other metabolic health markers. This dual mechanism is different from other treatments that typically target only one of these pathways.14678

What data supports the effectiveness of the drug tirzepatide for obesity?

Research shows that tirzepatide, a drug that helps control blood sugar and reduce appetite, is effective for weight loss in people with obesity and type 2 diabetes. It has been shown to lead to more weight loss compared to other similar treatments and also improves other health factors like blood pressure and fat levels.678910

Who Is on the Research Team?

LT

Lloyd Tran, PhD

Principal Investigator

Biomed Industries, Inc.

Are You a Good Fit for This Trial?

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

Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities
A written informed consent must be obtained before any study-related assessments are performed
My weight has been stable and is under 150 kg.
See 2 more

Exclusion Criteria

I haven't taken obesity medication in the last 30 days.
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
I have not lost or donated more than 400 mL of blood in the last 8 weeks or donated plasma in the last 14 days.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral NA-931 and/or Tirzepatide with dose escalation, with visits at baseline and Weeks 4, 12, 24, 36, and 48

48 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to receive NA-931 during the extension period at Weeks 60 and 72

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NA-931
  • Tirzepatide
Trial Overview 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.
How Is the Trial Designed?
9Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: NA-931 60mg to NA-931 150 mg + no TirzepatideExperimental Treatment1 Intervention
Group II: NA-931 150 mg + no TirzepatideExperimental Treatment2 Interventions
Group III: NA-931 150 mg + Tirzepatide 2.5 mgActive Control2 Interventions
Group IV: NA-931 60 mg + Tirzepatide 5 mgActive Control1 Intervention
Group V: NA-931 120 mg + Tirzepatide 5 mgActive Control1 Intervention
Group VI: NA-931 150 mg + Tirzepatide 5 mgActive Control1 Intervention
Group VII: Placebo Comparator: PlaceboPlacebo Group1 Intervention
Group VIII: Placebo + Tirzepatide 5 mgPlacebo Group2 Interventions
Group IX: Placebo + Tirzepatide 10 mgPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biomed Industries, Inc.

Lead Sponsor

Trials
9
Recruited
5,100+

Bioneurals Ltd

Collaborator

Trials
1
Recruited
220+

Published Research Related to This Trial

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.
While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.
Weight loss efficiency and safety of tirzepatide: A Systematic review.Lin, F., Yu, B., Ling, B., et al.[2023]
Tirzepatide, a once-weekly medication for type 2 diabetes, not only improves blood sugar control but also leads to significant weight loss and positive changes in cardiovascular health, such as reduced blood pressure and improved insulin sensitivity.
The weight loss and metabolic benefits of tirzepatide are linked to its dual action as a GIP and GLP-1 receptor agonist, suggesting that these mechanisms play a crucial role in its effectiveness for managing type 2 diabetes.
Perspectives on weight control in diabetes - Tirzepatide.Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]
Tirzepatide is a novel medication that acts on both GIP and GLP-1 receptors, enhancing insulin secretion and reducing glucagon levels, which helps improve glycemic control in adults with type 2 diabetes mellitus (T2DM).
It received its first approval in the USA in May 2022 for T2DM treatment and is currently being studied for additional conditions like obesity, heart failure, and non-alcoholic steatohepatitis, indicating its potential for broader therapeutic applications.
Tirzepatide: First Approval.Syed, YY.[2022]

Citations

Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]
Perspectives on weight control in diabetes - Tirzepatide. [2023]
Tirzepatide: First Approval. [2022]
Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]
A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? [2023]
Tirzepatide, a dual GIP/GLP-1 receptor co-agonist for the treatment of type 2 diabetes with unmatched effectiveness regrading glycaemic control and body weight reduction. [2022]
Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. [2023]
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