Aardvark pauses Phase 3 HERO trial for ARD-101
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial of ARD-101 in Prader-Willi syndrome, along with the related open-label extension.
Rhea-AI Filing Summary
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial of ARD-101 in Prader-Willi syndrome, along with the related open-label extension. The pause follows reversible cardiac observations at above target therapeutic doses seen during routine safety monitoring in a healthy volunteer study.
The company is conducting a comprehensive data review and has temporarily halted enrollment and dosing in HERO out of caution. As a result, Aardvark no longer expects to report topline HERO data in the third quarter of 2026 and plans to give updated timing guidance in the second quarter of this year.
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- Phase 3 program disruption: Voluntary pause of the HERO Phase 3 and open-label extension trials for ARD-101 due to reversible cardiac observations at above target therapeutic doses, with HERO topline data no longer expected in the third quarter of 2026 and timing now uncertain.
Insights
Voluntary Phase 3 pause introduces clinical and timing risk for ARD-101.
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial and open-label extension of ARD-101 in Prader-Willi syndrome after reversible cardiac observations at above target therapeutic doses in a healthy volunteer study. Enrollment and dosing are on hold while data are reviewed.
This development creates uncertainty around ARD-101’s safety profile and optimal dosing, which are critical for regulatory discussions and future commercialization. It also directly impacts the program’s timeline, as prior expectations for HERO topline data in the third quarter of 2026 are no longer valid.
Aardvark plans to provide further guidance in the second quarter of this year, which will be an important marker for understanding revised timing and any potential protocol or dosing changes. Until then, the program’s trajectory remains dependent on the outcome of the ongoing safety evaluation and interactions with the FDA.
8-K Event Classification
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Aardvark Therapeutics (AARD) announce about the HERO Phase 3 trial?
Why was Aardvark Therapeutics’ ARD-101 HERO trial voluntarily paused?
How does the HERO trial pause affect AARD’s topline data timeline?
What is ARD-101 and what condition is Aardvark targeting?
Are the cardiac observations with ARD-101 considered permanent or reversible?
What future updates has Aardvark Therapeutics committed to on ARD-101?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 8.01 Other Events.
On February 27, 2026, Aardvark Therapeutics, Inc. (the “Company”) issued a press release announcing that the Company is voluntarily pausing its Phase 3 Hunger Elimination or Reduction Objective (HERO) trial, which is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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Press Release, dated February 27, 2026. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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AARDVARK THERAPEUTICS, INC. |
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Tien-Li Lee, M.D. |
Exhibit 99.1
Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in
Prader-Willi Syndrome
SAN DIEGO, Feb. 27, 2026 (GLOBE NEWSWIRE) – Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced it is voluntarily pausing the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).
The decision by Aardvark to voluntarily pause the HERO (NCT06828861) and open-label extension (NCT07197034) trials was based on reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study. Aardvark is conducting a comprehensive review of the data to inform next steps. Out of an abundance of caution, the company has voluntarily paused ongoing enrollment and dosing in the HERO trial during this evaluation.
“The safety of every patient in our clinical studies is our highest priority, so we will thoroughly evaluate the signals seen at higher than therapeutic doses of ARD-101 in a healthy volunteer study,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We are committed to advancing the ARD-101 clinical program and we are evaluating optimal therapeutic dosing levels to support its progress. We will continue to collaborate closely with the FDA and scientific and clinical experts, and we greatly appreciate our partnership with the PWS community as we determine next steps for this program.”
Based on the ongoing activities in the ARD-101 program, Aardvark no longer anticipates announcing topline data from the HERO trial in the third quarter of 2026 and expects to provide further guidance in the second quarter of this year.
About ARD-101
ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed on the luminal side of the intestine. As a potent bitter taste receptor pan-agonist, ARD-101 stimulates enteroendocrine cells of the digestive tract to release multiple gut-peptide hormones, including GLP-1 and the satiety hormone cholecystokinin (CCK), which activates gut-brain neurologic signaling to mediate hunger. ARD-101 has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome (PWS).
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, through two separate Phase 2 trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting interim, preliminary or topline results, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-101, including the review of the data from the healthy volunteer study, the expected timeline for announcing topline data from the Phase 3 HERO trial, potential next steps for ARD-101, and Aardvark’s expected timing for providing further guidance. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that Aardvark filed with the Securities and Exchange Commission on November 13, 2025. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current
expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.
Investor Contact:
Courtney Mogerley
Argot Partners
(212) 600-1902
Aardvark@Argotpartners.com
Media Contact:
Andrea Cohen
Sam Brown LLC
(917) 209-7163
andreacohen@sambrown.com