ARD-101 for Obesity

Overseen By Andreas Niethammer, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aardvark Therapeutics, Inc.

Must not be taking: Antipsychotics, Anti-obesity drugs

Disqualifiers: Bariatric surgery, Heart failure, others

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

Compensation: Varies

Number of Visits: 15

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ARD-101, a twice-daily pill, to determine its safety and effectiveness for people with obesity. Participants will receive either ARD-101 or a placebo (a pill with no active ingredients) for 28 days. The trial targets individuals with a body mass index (BMI) between 30 and 45 who have maintained a stable weight over the past six months. It may suit those diagnosed with type 2 diabetes or prediabetes, provided they are not on diabetes medication other than metformin. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant obesity research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are on diabetes treatments other than metformin, chronic oral steroids, immune modulators, anti-obesity drugs, chronic opiate therapy, or antipsychotic medications. It's best to discuss your specific medications with the study team.

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

Research has shown that ARD-101 is generally safe for people. In a study with 42 healthy adults, all doses of ARD-101 were well-tolerated. Other studies have found that while ARD-101 mainly affects the gut, it also influences the whole body by activating certain gut hormones. These studies did not identify any major safety issues. This suggests ARD-101 might be safe for people with obesity, but consulting a healthcare professional before joining a trial is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ARD-101 is unique because it offers a fresh approach to tackling obesity. Unlike standard treatments like appetite suppressants or metabolic boosters, ARD-101 has a novel mechanism of action that researchers believe could target obesity more effectively. This new drug is designed to be taken as a pill twice a day, potentially making it more convenient and appealing for patients compared to other treatments that may require injections or more complex regimens. Researchers are excited about ARD-101 because it could provide faster results with fewer side effects, offering a promising new option for those struggling with obesity.

What evidence suggests that ARD-101 could be an effective treatment for obesity?

Research has shown that ARD-101, which participants in this trial may receive, yields promising results in reducing hunger and body fat. In studies involving individuals with Prader-Willi Syndrome, those taking ARD-101 reported feeling significantly less hungry compared to those taking a placebo, a pill with no active medicine. Specifically, hunger decreased 2.51 times more in those taking ARD-101. Caregivers also observed an average decrease of 8.5 points in hunger-related behaviors. These findings suggest that ARD-101 could help manage hunger and potentially support weight loss. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures

BMI of 30-45 kg/m2

Stable body weight by subject report (± 5%) in the previous 6 months prior to randomization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive ARD-101 or placebo, 200 mg twice daily for 28 days

4 weeks

Periodic visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

End-of-Study Visit within 14 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• ARD-101
• Placebo

How Is the Trial Designed?

Group I: ARD-101 Experimental Treatment 1 Intervention

Dose 200 mg of ARD-101, twice daily for 28 days

Group II: Placebo Comparator Placebo Group 1 Intervention

Placebo arm matching active arm ARD-101, 200 mg BID

Who Is Running the Clinical Trial?

Aardvark Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

150+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

In a five-year analysis of 1,559 healthy volunteers across 142 phase I studies, the overall incidence of adverse events (AEs) was 8.8%, with most AEs being mild or moderate in severity, indicating that while AEs are common, they are generally not severe.

The incidence of AEs was significantly higher in multiple-dose studies compared to single-dose trials, highlighting the importance of study design in assessing the safety profile of active drugs, with a notable increase in AEs on the first day of drug administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects. Lutfullin, A., Kuhlmann, J., Wensing, G.[2019]

The study analyzed adverse event (AE) data from six randomized controlled trials involving schizophrenia treatments, highlighting that the absolute prevalence and expected duration of AEs provide a more comprehensive understanding of a drug's safety compared to just incidence rates.

Using a new metric to assess the drug-placebo difference in AE prevalence, the research found that some AEs not listed in the standard drug label significantly impacted drug tolerability, suggesting that including these metrics in drug labels could enhance safety signal detection and inform better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. Piacentino, D., Ogirala, A., Lew, R., et al.[2023]

Citations

1. ir.aardvarktherapeutics.com ir.aardvarktherapeutics.com/news-releases/news-release-details/aardvark-therapeutics-reports-positive-phase-ii-clinical-data

Aardvark Therapeutics Reports Positive Phase II Clinical ... ARD-101 shows strong efficacy signals including reduction of hunger and body fat composition in the treatment of Prader-Willi Syndrome, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06828861

ARD-101 for Treatment of PWS: The Hunger Elimination or ... The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS).

3. praderwillinews.com praderwillinews.com/news/ard-101-phase-3-trial-expands-pws-patients-young-10/

ARD-101 Phase 3 trial expands to PWS patients as young ... Results showed that caregivers reported an average 8.5-point drop on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), reflecting a ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/aardvark-therapeutics-ard-101/

Aardvark Therapeutics posts positive data from ARD-101 ... It found that patients who received ARD-101 experienced a 2.51 times greater reduction in hunger rating than those who were given placebo, with ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/aardvark-gets-fda-alignment-for-prader-willi-phase-3-trial/

Aardvark Gets FDA Alignment for Prader-Willi Phase 3 Trial Aardvark Therapeutics lowered the minimum age of eligibility in its Phase 3 HERO trial of ARD-101 for hyperphagia in Prader–Willi syndrome ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05153434

A Study of Oral ARD-101 in Patients With Prader-Willi ... This Phase 2 study evaluates the safety and efficacy of ARD-101 in patients with Prader-Willi Syndrome, including a screening, treatment, and follow-up period.

7. prnewswire.com prnewswire.com/news-releases/aardvark-therapeutics-reports-positive-phase-ii-clinical-data-for-ard-101-301848268.html

Aardvark Therapeutics Reports Positive Phase II Clinical ... ARD-101 is shown to be safe and substantially gut-restricted; yet it conveys systemic effects via activation of gut peptide hormone secretion, ...