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Anti-obesity Agent

Part 1 - Single Ascending Dose for Obesity

Phase 1
Recruiting
Research Sponsored by NeuroBo Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of non-reproductive potential: Postmenopausal or with history of hysterectomy or bilateral oophorectomy
Males and females >18 to <65 years of age, diagnosed with obesity or signs/symptoms consistent with obesity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 days for part 1 and 47 days for part 2.
Awards & highlights

Study Summary

This trial is testing a new drug called DA-1726 in people who are obese but otherwise healthy. The main goal is to see if the drug is safe and well-tolerated when given in

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is a first-in-human study, specific side effects of DA-1726 aren't listed but may include typical drug reactions like digestive issues, allergic responses, fatigue, or other unexpected symptoms as observed during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman who cannot have children because I am postmenopausal or have had surgery.
Select...
I am between 18 and 65 years old and have been diagnosed with obesity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 days for part 1 and 47 days for part 2.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization (baseline) until the discontinuation or completion, whichever came first, assessed up to 26 days for part 1 and 47 days for part 2. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
Immunogenicity
Pharmacokinetic

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Part 1 - Single Ascending DoseActive Control2 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 DosePlacebo Group2 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.

Find a Location

Who is running the clinical trial?

NeuroBo Pharmaceuticals Inc.Lead Sponsor
14 Previous Clinical Trials
1,252 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria to participate in this medical study?

"Individuals meeting the eligibility criteria must have a body mass index indicative of obesity and fall within the age range of 18 to 65 years old. The trial has openings for up to 81 participants in total."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"The information available on clinicaltrials.gov reveals that this particular research endeavor is not currently seeking volunteers. Its initial posting was made on March 1st, 2024, with the latest revision dated February 7th of the same year. Although inactive now, it's noteworthy that there are an extensive 958 ongoing trials actively enrolling participants."

Answered by AI

Does this medical study include individuals aged 85 and above as participants?

"Individuals aged between 18 and 65 are eligible to participate in this trial as per the inclusion criteria. Notably, there are a total of 175 trials focused on individuals under 18 years old, while 608 trials cater to those above the age of 65."

Answered by AI

Does the FDA endorse Part 1 - Single Ascending Dose of this study?

"According to our assessment at Power, the safety rating for Part 1 - Single Ascending Dose is a level 1. This reflects that as it is a Phase 1 trial, there exists only minimal data supporting both its safety and effectiveness."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First in Human Study in Subjects With Obesity, But Otherwise Healthy
2024. "First in Human Study in Subjects With Obesity, But Otherwise Healthy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252220.
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~54 spots leftby Dec 2024
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