NA-931 and Tirzepatide for Obesity

Not yet recruiting at 19 trial locations

Overseen By Lloyd Tran, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biomed Industries, Inc.

Must not be taking: Antidiabetics, Obesity medications

Disqualifiers: Diabetes, Chronic infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of NA-931 and Tirzepatide (a medication for weight management) alone or in combination for safe weight loss. It targets individuals who are overweight or obese, particularly those who have previously struggled with weight loss. Participants should have a BMI of 30 or above, or a BMI of 27 or above with additional health conditions such as high blood pressure or sleep apnea. The trial aims to evaluate the effectiveness of these treatments in promoting weight loss. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that NA-931 helped people lose weight and caused fewer and milder side effects compared to other treatments. As a pill, it is easy to take and was found to be safe, suggesting that most people can use it without problems.

Research on Tirzepatide, already approved for other uses, shows it also aids in weight loss. However, it can cause some side effects, mostly related to the stomach, such as nausea or diarrhea. These side effects are uncommon but can occur.

Overall, both treatments are generally safe. NA-931 has fewer side effects compared to injectable treatments. Tirzepatide's safety is supported by its previous approval for other conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of NA-931 and Tirzepatide for obesity because these treatments offer a potentially novel approach compared to existing options like lifestyle changes, orlistat, and GLP-1 receptor agonists. NA-931 is being explored for its unique mechanism as a potential oral anti-obesity agent, while Tirzepatide is a dual GIP and GLP-1 receptor agonist, which might offer enhanced weight loss effects. The combination of these two could provide a more powerful and complementary approach to weight management, targeting multiple pathways involved in obesity. This could lead to more effective and sustainable weight loss outcomes for patients struggling with obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that NA-931, one of the treatments in this trial, holds promise for weight loss. In one study, participants taking a 150 mg dose lost an average of 14.8% of their body weight by week 13, which was 13.2% more than those taking a placebo, a pill with no active ingredients. Another treatment option in this trial, Tirzepatide, has also proven effective for significant weight loss, with some individuals losing over 20% of their body weight. This trial will explore the potential benefits of combining NA-931 and Tirzepatide, which might increase effectiveness and reduce side effects. ^{2 4 5 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: NA-931 60mg to NA-931 150 mg + no Tirzepatide Experimental Treatment 1 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 Tirzepatide Experimental Treatment 2 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 mg Active Control 2 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 mg Active Control 1 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 mg Active Control 1 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 mg Active Control 1 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: Placebo Placebo Group 1 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 mg Placebo Group 2 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 mg Placebo Group 2 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.

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, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on weight control in diabetes - Tirzepatide. Várkonyi, TT., Pósa, A., Pávó, N., et al.[2023]

Tirzepatide, approved in 2022, is a novel treatment for type 2 diabetes that acts on both GLP-1 and GIP pathways, showing significant efficacy in lowering blood sugar levels and promoting weight loss in various patient groups.

Clinical trials, including the SURPASS and SURMOUNT studies, indicate that tirzepatide has a safety profile similar to traditional GLP-1 receptor agonists, with common gastrointestinal side effects, making it a promising option for patients needing better glycemic and weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: Clinical review of the "twincretin" injectable. Krauss, Z., Hintz, A., Fisk, R.[2023]

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, has a safety profile similar to other GLP-1 receptor agonists, but higher doses (10mg and above) are associated with increased risks of hypoglycemia and treatment discontinuation.

In clinical trials involving 9818 patients, higher doses of tirzepatide led to more frequent gastrointestinal side effects like nausea, vomiting, and diarrhea, indicating that these adverse events are dose-dependent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the safety of tirzepatide-a new dual GLP1 and GIP agonist - is its safety profile acceptable? Meng, Z., Yang, M., Wen, H., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review. Lin, F., Yu, B., Ling, B., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: First Approval. Syed, YY.[2022]

Tirzepatide, a once-weekly GIP/GLP-1 receptor agonist, is being evaluated in a large cardiovascular outcomes trial involving 13,299 participants with type 2 diabetes and established cardiovascular disease to assess its safety and efficacy compared to dulaglutide.

The primary goal of the trial is to determine if tirzepatide is noninferior to dulaglutide in preventing major adverse cardiovascular events (MACE), which will help establish its cardiovascular benefits in this patient population.

NCBI (Pubmed)

pubmed.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. Nicholls, SJ., Bhatt, DL., Buse, JB., et al.[2023]

Tirzepatide, a dual GIP and GLP-1 receptor agonist, showed significant reductions in Hemoglobin A1c levels (up to 3.02%) and weight loss in adults with uncontrolled type 2 diabetes, outperforming both placebo and active comparators like semaglutide.

The safety profile of tirzepatide was comparable to semaglutide regarding gastrointestinal adverse effects, and it did not increase the incidence of major cardiovascular events compared to insulin glargine, indicating it may be a valuable addition to diabetes treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, the Newest Medication for Type 2 Diabetes: A Review of the Literature and Implications for Clinical Practice. Bradley, CL., McMillin, SM., Hwang, AY., et al.[2023]

Tirzepatide, the first dual GIP/GLP-1 receptor co-agonist approved for type 2 diabetes, significantly reduces HbA1c levels (by 1.24 to 2.58%) and body weight (by 5.4-11.7 kg) in clinical trials involving type 2 diabetic patients, outperforming the selective GLP-1 RA semaglutide.

The safety profile of tirzepatide is similar to that of other GLP-1 receptor agonists, with common side effects including nausea and diarrhea, and it shows potential cardiovascular safety, as no significant increase in major adverse cardiovascular events was observed during the trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Nauck, MA., D'Alessio, DA.[2022]

Tirzepatide demonstrated a dose-dependent ability to lower HbA1c levels in adults with type 2 diabetes, with reductions ranging from -17.71 to -22.35 mmol/mol compared to placebo, and was also more effective in reducing body weight than other treatments.

While tirzepatide did not increase the risk of hypoglycaemia compared to placebo and showed lower rates than basal insulin, it was associated with a higher incidence of gastrointestinal side effects, particularly nausea and vomiting, especially at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

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This Phase 2 study investigates if NA-931 in addition to Tirzepatide can demonstrate synergic effects by enhancing efficacy and reducing adverse events ...

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The analysis positions NA-931 as a major advancement, combining oral convenience with superior safety compared to current injectable treatments.