Study to Evaluate ARD-101 in Adults With 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

20 Participants Needed

Trial Summary

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.

What safety data exists for the treatment known as ARD-101, Placebo, Control, or Dummy Treatment?

The research articles do not provide specific safety data for ARD-101, but they discuss adverse events (side effects) in general for drugs and placebos in clinical trials. This includes how often side effects happen and how they compare to placebos, but no specific safety information for ARD-101 is mentioned. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing ARD-101, a medication taken regularly, in obese individuals with a BMI between 30 and 45. The drug works by interacting with taste receptors to help manage weight.

Eligibility Criteria

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

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

Treatment Details

Interventions

• ARD-101
• Placebo

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States 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. [2023]

2. Greece pubmed.ncbi.nlm.nih.gov

Anemia in Placebo Arms of Cancer Studies. [2021]

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

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Dataset for amiodarone adverse events compared to placebo using data from randomized controlled trials. [2020]

5. Germany 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. [2019]