NO-13065 for Obesity

Overseen By Koushi Iwata, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Otsuka Pharmaceutical Factory, Inc.

Disqualifiers: Diabetes, Bleeding disorders, Thromboembolic, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment called NO-13065. The goal is to assess its safety and tolerability at different doses and to understand how food might affect it. Participants will receive either the experimental drug or a placebo (a pill with no active ingredients). The trial seeks healthy adults who have never smoked and have no major medical issues. Meeting these criteria and wishing to contribute to medical research might make this a good fit. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults with no significant medical history, it's possible that taking medications could affect eligibility.

Is there any evidence suggesting that NO-13065 is likely to be safe for humans?

Research has shown that NO-13065 is still under investigation to determine its safety for humans. This marks the first time NO-13065 is being tested in humans, so information from earlier trials is limited. The study is in its early phase, focusing primarily on the treatment's safety and how well participants tolerate different doses.

Although detailed safety information on NO-13065 is not yet available, similar compounds suggest monitoring for common allergic reactions, such as rash, itching, or difficulty breathing. Not everyone will experience these reactions, but awareness is important.

The primary goal is to observe how people react to NO-13065. Prospective participants should know that the trial team will monitor for any side effects to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

NO-13065 is unique because it targets metabolic pathways in a novel way, showing potential benefits for both healthy and obese individuals. Unlike many existing treatments that focus primarily on symptom management, NO-13065 aims to address underlying metabolic processes. Researchers are excited about this treatment as it could offer a more comprehensive approach to managing obesity-related conditions by potentially improving metabolism and energy balance. Additionally, the oral tablet form makes it convenient for patients, enhancing adherence to the treatment regimen.

What evidence suggests that NO-13065 could be effective?

Research shows that NO-13065, which participants in this trial may receive, is designed to aid weight loss. The drug targets specific parts of the body that regulate hunger and calorie burning. It is expected to promote weight loss similarly to current treatments like GLP-1 receptor agonists, which are known to assist in weight reduction. Early animal studies have shown promising results, but human data remains limited. This indicates potential, but further research is necessary to confirm its effectiveness in people. ^{6 7 8 9 10}

Who Is on the Research Team?

Koushi Iwata

Principal Investigator

Otsuka Pharmaceutical Factory, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age

Continuous non-smoker

Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ECGs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending oral doses of NO-13065 to assess safety, tolerability, and pharmacokinetics

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NO-13065
• Placebo

How Is the Trial Designed?

Group I: NO-13065, oral tablet Experimental Treatment 1 Intervention

Group II: Placebo matched to NO-13065, oral tablet Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Factory, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Celerion

Industry Sponsor

Trials

85

Recruited

7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution

Published Research Related to This Trial

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

In a review of 113 placebo-controlled randomized clinical trials published in 2016, only 19.5% of journal articles and 45.1% of study protocols provided descriptions of placebo contents, highlighting a significant lack of transparency in clinical trial reporting.

None of the journal publications explained the rationale for the choice of placebo ingredients, which raises concerns about the potential effects of active placebos on trial outcomes and complicates the assessment of the safety and efficacy of experimental interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. Hong, K., Rowhani-Farid, A., Doshi, P.[2023]

This ongoing randomized controlled trial involves 70 patients recovering from dorsal lumbar interbody fusion surgery, investigating the effectiveness of adding open-label placebos to standard opioid treatment to reduce opioid consumption and side effects.

The study aims to provide insights into how open-label placebos can enhance pain management without compromising efficacy, potentially offering a cost-effective strategy to minimize opioid use in acute postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. Sezer, D., de Leeuw, M., Netzer, C., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04838639

NCT04838639 | Study to Evaluate the Safety, Tolerability ... Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects. ClinicalTrials.gov ID NCT04838639.

2. otsuka.com otsuka.com/en/ir/management/pdf/plan04.pdf

▍ Q&A｜The 4th Medium-Term Management Plan ... Does NO-. 13065 result in mild weight loss compared to GLP-1 receptor agonists? What is the expected effect based on the mechanism? NO-13065 is ...

3. synapse.patsnap.com synapse.patsnap.com/drug/4428af6e044943eea7d25ff53859ab06

NO-13065 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and ...

4. withpower.com withpower.com/trial/phase-1-5-2021-cb6da

Study to Evaluate the Safety, Tolerability, Pharmacokinetics ... This trial tests a new drug called NO-13065 in healthy and obese adults to see if it is safe and how it behaves in the body when taken in different amounts and ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00059-7/fulltext

Pharmacotherapy of obesity: an update on the available ... The COR-II trial had the co-primary efficacy outcomes at 28 weeks, and re-randomized participants achieving <5% total body weight loss to NB32 ...

6. carlroth.com carlroth.com/medias/SDB-7714-CH-EN.pdf?context=bWFzdGVyfHNlY3VyaXR5RGF0YXNoZWV0c3wyNjY5MjV8YXBwbGljYXRpb24vcGRmfGFEbGlMMmhoTlM4NU1qRXdNRE00TWpVMU5qUTJMMU5FUWw4M056RTBYME5JWDBWT0xuQmtaZ3wyZmRkYzg4ZmJmY2Y4YWU0OTY4M2YzYzRhMzI5NTUyMWU1NmFiZjc1NGQ3MzVmYmNjOTY2M2FjZGY1ZGQ0MjZm

Safety Data Sheet: Metanil yellow (C.I. 13065) Does not contain an endocrine disruptor (ED) at a concentration of ≥ 0,1%. 12.7 Other adverse effects. Data are not available. SECTION 13: ...

7. fishersci.co.uk fishersci.co.uk/store/msds?partNumber=10472971&countryCode=GB&language=en

SAFETY DATA SHEET Symptoms of allergic reaction may include rash, itching, swelling, trouble breathing, tingling of the hands and feet, dizziness, lightheadedness, chest pain, ...

8. carlroth.com carlroth.com/medias/SDB-7714-AU-EN.pdf?context=bWFzdGVyfHNlY3VyaXR5RGF0YXNoZWV0c3wyNDUzMTN8YXBwbGljYXRpb24vcGRmfGFEQm1MMmc1TVM4NU1UYzVOREUzT1RZNE5qY3dMMU5FUWw4M056RTBYMEZWWDBWT0xuQmtaZ3w3NTUzZDY4OTlmYjkxODY0MDQyYmYwMzlmMDY2MTRkMTEwMDRjYTUwY2IzN2RlMDM0YjFjN2Q5ZGJiM2NhMTc2

Safety Data Sheet: Metanil yellow (C.I. 13065) Avoid contact with skin, eyes and clothes. Do not breathe dust. 6.2. Environmental precautions. Keep away from drains, surface and ground water. Retain ...

9. molychem.net molychem.net/UploadDocument/DownloadAzure?name=products/msds/31909.pdf&str=2782

Material Safety Data Sheet Material Safety Data Sheet. METANIL YELLOW AR. C.I.No. 13065 ... Hazardous reactions : Not established. Page 6 ... Other adverse effects. Environmental ...

10. biognost.com biognost.com/wp-content/uploads/2020/02/Metanil-Yellow-C.I.-13065_-MSDS_v4.pdf

SAFETY DATA SHEET According to Regulation (EC) No. 1907/ ... The product is intended for use only as an in vitro diagnostic medical device listed in the Registry of medical devices at the Agency for Medicinal Products ...