DA-1726 for Obesity

Overseen By Ji Eun Lee, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NeuroBo Pharmaceuticals Inc.

Must not be taking: Corticosteroids, Antipsychotics, Antidepressants, others

Disqualifiers: Diabetes, Cardiac conditions, Substance abuse, others

Compensation: Varies

Number of Visits: Unknown

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, DA-1726, to determine its safety and tolerability for individuals with obesity. It consists of two parts: one examines the effects of a single dose, while the other investigates multiple doses. The trial seeks volunteers diagnosed with obesity, with a BMI between 30 and 45, who are otherwise healthy. Participants will receive DA-1726 via injection and must maintain their current diet and exercise routines. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are taking medications that can cause significant weight gain or are part of an organized weight reduction program, you may need to stop those before joining the trial.

Is there any evidence suggesting that DA-1726 is likely to be safe for humans?

Research has shown that DA-1726 is likely safe for humans. In a 28-day study with 36 participants, DA-1726 proved to be very safe and well-tolerated. The study demonstrated positive effects without major safety issues. Another study found that DA-1726 was gentler on the body compared to other treatments like GLP-1 agonists, which are common obesity drugs. Overall, these findings suggest that DA-1726 could be a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

DA-1726 is unique because it offers a new approach to tackling obesity. Unlike current treatments that often rely on lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as liraglutide, DA-1726 is administered through subcutaneous injections and is being explored for its potential to directly influence metabolic processes. Researchers are excited about DA-1726 because it promises a novel mechanism that could more effectively manage weight in adults with obesity, potentially offering better outcomes and convenience compared to existing therapies.

What evidence suggests that DA-1726 might be an effective treatment for obesity?

Research has shown that DA-1726 may aid in weight loss. In one study, participants taking the highest dose of 32 mg lost an average of 4.3% of their body weight in four weeks. Another study found that weight loss could reach up to 6.3% without changing the dose over time. DA-1726 also increases energy use, which can aid in losing weight. This trial will evaluate DA-1726 in two parts: Part 1 involves a single ascending dose, and Part 2 involves multiple ascending doses. Compared to another drug, tirzepatide, DA-1726 led to more weight loss even when participants consumed similar amounts of food. These findings suggest that DA-1726 could be an effective option for weight loss. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with obesity (BMI >30 to <45), who are otherwise healthy. Women must be non-reproductive, and men should use birth control during the study. Participants can't have had significant weight changes or started new diets/exercise in the last 3 months, and they must not use tobacco or have certain medical conditions.

Inclusion Criteria

I am generally healthy based on recent medical exams and tests.

I am a woman who cannot have children because I am postmenopausal or have had surgery.

Body mass index (BMI) > 30 kg/m2 to 45 kg/m2 (Obesity confirmed by Caliper test)

Exclusion Criteria

History or presence of psychiatric disorders affecting safety or compliance

I have a history of health issues affecting how my body processes or gets rid of drugs.

I have a long-term heart, liver, or kidney condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive single doses of DA-1726 via subcutaneous injection

26 days

Multiple visits (in-person)

Multiple Ascending Dose

Participants receive multiple doses of DA-1726 via subcutaneous injection

47 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DA-1726

Trial Overview

The trial tests DA-1726 against a placebo in people with obesity. It aims to check how safe it is and how well participants tolerate different doses over time. The study involves single and multiple dose administrations while maintaining a standard diet.

How Is the Trial Designed?

Group I: Part 1 - Single Ascending Dose Active Control 2 Interventions

Single doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.

Group II: Part 2 - Multiple Ascending Dose Placebo Group 2 Interventions

Multiple doses of DA-1726 in adult participants (aged 18 to 65 years) with obesity (BMI ≥30 - 45 kg/m2). DA-1726 will be administered via subcutaneous (SC) injection within the clinic setting.

Who Is Running the Clinical Trial?

NeuroBo Pharmaceuticals Inc.

Lead Sponsor

Trials

15

Recruited

1,300+

Published Research Related to This Trial

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Abdominal obesity, particularly the accumulation of visceral fat, is a major contributor to metabolic syndrome and significantly increases the risk of coronary heart disease and type 2 diabetes.

Rimonabant, a CB1 receptor blocker, shows promise in managing cardiovascular disease risk factors in abdominally obese patients by improving energy metabolism and adipose tissue function, potentially reducing cardiometabolic risks even without weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of CB1 blockade to the management of high-risk abdominal obesity. Després, JP., Lemieux, I., Alméras, N.[2018]

Bariatric surgery is effective for weight loss and resolving obesity-related health issues, but it has limitations and risks, highlighting the need for safe and effective anti-obesity medications (AOMs).

Currently, five AOMs are approved for long-term weight management, with additional promising drugs in phase 3 trials, emphasizing the importance of personalized treatment plans by healthcare professionals for effective obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approved Anti-Obesity Medications in 2022 KSSO Guidelines and the Promise of Phase 3 Clinical Trials: Anti-Obesity Drugs in the Sky and on the Horizon. Jeon, E., Lee, KY., Kim, KK.[2023]

Obesity is a major public health crisis, with limited effectiveness of current diet and lifestyle interventions, highlighting the urgent need for effective treatments.

While there are promising anti-obesity drugs in development, they face significant challenges due to past issues with safety and efficacy, but there is hope that future treatments will be as safe and accepted as those for other metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-obesity drug development. Bays, H., Dujovne, C.[2019]

Mild to moderate obesity affects public health more significantly than severe obesity, indicating a need for effective management strategies targeting this larger population.

An individualized approach to obesity treatment, along with advancements in pharmacologic therapies, may offer better outcomes compared to traditional lifestyle and behavioral modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical therapy for obesity. Dayyeh, BK., Kaplan, LM.[2011]

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Compared to tirzepatide, DA-1726 produced greater weight loss despite similar food intake, accompanied by enhanced energy expenditure not ...

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MetaVia to Present New Phase 1 and Pre-Clinical Data ...

Compared to tirzepatide, DA-1726 produced greater weight loss despite similar food intake, accompanied by enhanced energy expenditure not ...

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Results from the Phase 1 study show that, at the highest dose (32 mg), participants achieved an average weight loss of 4.3% over four weeks, ...

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NeuroBo Pharmaceuticals Announces Positive Top-Line ...

The company is currently developing DA-1726 for the treatment of obesity, and is developing DA-1241 for the treatment of Metabolic Dysfunction- ...