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RETATRUTIDE INVESTIGATIONAL COMPOUND

ENHANCED INFORMED CONSENT AND ASSUMPTION OF RISK

WARNING: MAXIMUM RISK WARNING

Retatrutide (LY3437943) is an INVESTIGATIONAL COMPOUND that is NOT FDA-approved for any use. It is not a component of any FDA-approved drug. There is NO legal compounding pathway for retatrutide under FDCA Section 503A or 503B. The FDA has sent letters to state boards of pharmacy specifically warning that retatrutide cannot be used in compounded drug products. Ohio has announced immediate licensure suspension for anyone compounding, selling, or administering retatrutide. By signing this document, you acknowledge and assume extraordinary risks.

WHAT IS RETATRUTIDE?

Retatrutide is Eli Lilly’s first-in-class triple hormone receptor agonist targeting GIP, GLP-1, and glucagon receptors simultaneously. It is currently in Phase 3 clinical trials (the TRIUMPH program). The first Phase 3 results (TRIUMPH-4, December 2025) showed up to 28.7% weight loss at 68 weeks. A potential NDA submission is projected for Q4 2026/Q1 2027, with possible FDA approval in late 2027 at the earliest.

REGULATORY STATUS
  • Retatrutide is NOT FDA-approved for any indication.
  • It is NOT a component of any FDA-approved drug product.
  • It does NOT appear on the FDA 503A or 503B bulks list and has NO USP monograph.
  • There is NO legal pathway for compounding retatrutide.
  • The FDA has specifically warned state boards that retatrutide cannot be used in compounding.
  • Multiple states (including Ohio) have announced immediate enforcement action.
  • Any retatrutide obtained outside of a registered clinical trial is unapproved and unregulated.
RISKS

The full risk profile is unknown. Known risks from clinical trial data include all GLP-1 agonist risks (nausea, vomiting, diarrhea, gastroparesis, pancreatitis, thyroid tumor risk) PLUS risks from glucagon receptor activation (increased heart rate, lipid metabolism effects, potential hepatic effects). Unknown long-term risks may emerge.

ASSUMPTION OF RISK
  • I understand retatrutide is investigational and NOT FDA-approved.
  • I understand there is NO legal compounding pathway.
  • I understand the full risk profile is unknown.
  • I voluntarily assume ALL risks, known and unknown.
  • I release FRONT LINE, its owners, employees, and affiliates from liability for adverse outcomes.
  • I have had the opportunity to ask questions and received satisfactory answers.
  • I understand I may discontinue treatment at any time.