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

Trial Summary

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.

What makes the drug DA-1726 unique for treating obesity?

The drug DA-1726 is unique because it may target specific mechanisms related to energy metabolism and adipose tissue, potentially offering a novel approach compared to existing obesity treatments that focus on general weight loss. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a First in Human study to evaluate the safety and tolerability of DA-1726 following single and multiple doses in participants with obesity, but otherwise healthy subjects.

Eligibility Criteria

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

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.

Obesity induced by other endocrinologic disorders

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Medical therapy for obesity. [2011]

2. Korea (South) 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Anti-obesity drug development. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Contribution of CB1 blockade to the management of high-risk abdominal obesity. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. [2018]