Eloralintide

What it is

Eloralintide is a long-acting peptide analog designed to favor the AMY1 receptor. FDA's substance record connects that candidate to LY3841136, LY-3841136, USAN LM-232, and UNII 73G3354J8W. Those identifiers follow one defined development drug.

The candidate name and receptor description do not authenticate sequence, concentration, purity, sterility, stability, excipients, or delivery system. Trial formulations do not establish the identity of another product or another amylin analog.

Why people care

Interest centers on the phase 2 weight-change findings, the proposed AMY1R preference, and entry into phase 3. Those features make it important to separate receptor and animal evidence from human outcomes and to distinguish registered combination studies from reported interaction results.

What humans actually show

Eloralintide is an investigational long-acting peptide analog with preferential agonism at the amylin receptor subtype AMY1R. Randomized phase 1 and phase 2 studies report body-weight and adverse-event findings, and phase 3 studies are registered, but the record does not establish FDA approval, long-term benefit, receptor-selectivity-based clinical superiority, combination safety, or another product's identity.

• randomized human — 263 U.S. adults with obesity, or overweight with a related comorbidity, without type 2 diabetes; Route: Subcutaneous study formulation; Outcome: Body-weight change and treatment-emergent adverse events through 48 weeks: Reported mean body-weight changes ranged from -9.0% to -20.0% across eloralintide groups versus -0.4% with placebo. Nausea ranged from 11% to 64% versus 14% with placebo, and fatigue ranged from 0% to 46% versus 12%. The seam: Phase 2 with 263 participants and group-specific exposure patterns; Weight rather than long-term morbidity or mortality; Excluded type 2 diabetes; Sponsor funded; Does not establish approval, rare or delayed risks, maintenance, comparative clinical benefit, or combination safety.
• randomized human — 100 adults with obesity or overweight in a phase 1 multiple-ascending study; Route: Subcutaneous study formulation; Outcome: Safety, tolerability, pharmacokinetics, and body-weight change through 12 weeks: Reported mean body-weight changes ranged from -2.6% to -11.3% across studied groups. Decreased appetite, headache, and fatigue were the most common treatment-emergent adverse events; 13 participants discontinued because of adverse events. The seam: Phase 1, short duration, and small groups; Adverse-event observations cannot define incidence, causality, or rare risk; The report describes mood-related discontinuations and one acute kidney injury considered unrelated by the investigator; these observations do not establish candidate causality or a labeled warning; No active-comparator or combination conclusion.
• randomized human — 48 healthy participants in a first-in-human single-ascending study; Route: Subcutaneous study formulation; Outcome: Safety, tolerability, pharmacokinetics, and short-term body-weight change: Nine participants reported 16 treatment-emergent adverse events, 15 of them mild. Selected groups had reported week-4 mean body-weight changes of -2.5% and -4.4% versus +0.6% with placebo. The seam: Small, short, first-in-human component; Healthy-participant population; Cannot establish a clinical weight-management benefit, uncommon risks, or long-term safety.

Mechanistic and nonhuman evidence

• mechanistic — Human receptor assay systems; Route: In-vitro assays; Outcome: Activity at AMY1R relative to calcitonin receptor and AMY3R systems: The discovery paper reported preferential agonism at human AMY1R in the tested systems. The seam: Receptor-system evidence; Does not establish clinical superiority, reduced adverse effects, net benefit, or product equivalence.
• animal — Rat and nonhuman-primate models; Route: Experimental administration in nonhuman models; Outcome: Food intake and body weight: The discovery paper reported reduced food intake and body weight in the tested nonhuman models. The seam: Animal evidence; Cannot establish human efficacy, clinical outcomes, comparative benefit, or long-term human safety.

FDA and U.S. status

An exact-active-ingredient Drugs@FDA API search returned no matching eloralintide application, and the name did not appear on FDA's 2026 novel-drug approvals page in this dated review. ClinicalTrials.gov records recruiting phase 3 studies. Trial registration is not FDA approval, and the exact-name database results are not converted into a broader legal conclusion.

Risks and warning limits

• human trial: Nausea and fatigue were the most frequent adverse events in the phase 2 trial, with substantially different frequencies across groups.
• human trial: Decreased appetite, headache, and fatigue were most common in the phase 1 multiple-ascending study; adverse-event discontinuations require event-level interpretation and do not by themselves establish labeled warnings.
• not characterized: No FDA-approved eloralintide prescribing information was located, so candidate-specific contraindications, warnings, pregnancy provisions, interactions, and postmarketing findings are not available to reproduce.

What remains unknown

• Whether phase 3 programs will complete and confirm efficacy, safety, maintenance, and clinical outcomes remains unknown.
• Results and full methods from the completed eloralintide-tirzepatide phase 1 study and ongoing phase 2 combination study were not posted in the reviewed records.
• Long-term and uncommon adverse effects, outcomes after treatment ends, and comparative benefit and harm versus approved treatments remain unresolved.

Product identity and quality limits

• Eloralintide, LY3841136, and LY-3841136 map to a defined development candidate but do not authenticate a finished product.
• The name or AMY1R description does not establish sequence, concentration, purity, sterility, stability, excipients, or delivery system.
• Evidence for eloralintide cannot be transferred to pramlintide, cagrilintide, petrelintide, native amylin, or an unidentified material.

What has been studied together

• Tirzepatide — coadministration studied: A completed 188-participant phase 1 study and an active phase 2 study register eloralintide with tirzepatide, but neither reviewed ClinicalTrials.gov record posted results. Registration does not establish benefit, absence of interaction, tolerability, or clinical clearance.
• Background weekly incretin therapy — coadministration studied: A recruiting phase 3 study registers eloralintide on background weekly incretin therapy. It has no results and cannot support an interaction or benefit conclusion.

What people are hearing

These are claims this profile checks, not established conclusions.

• Claim under review: “Eloralintide is approved because phase 3 trials are recruiting.”
• Claim under review: “AMY1R preference proves better clinical efficacy or safety.”
• Claim under review: “Eloralintide is already known to be safe and effective with tirzepatide.”

Questions readers raise

• No reproducible community sample was collected for this profile.

The community-signal layer is not efficacy or safety evidence. Its current limits are:

• No reproducible community sample was collected for this research draft.
• Online product identity cannot be verified from a name or self-report.
• Concurrent medicines, behaviors, and clinical conditions would confound anecdotal outcomes.
• Anecdotes cannot establish efficacy, safety, approval, interaction safety, or product quality.

What would change this answer

• Completed, fully reported phase 3 studies with efficacy, safety, maintenance, and clinical outcomes would materially change the evidence assessment.
• FDA approval documentation and current prescribing information for a defined eloralintide product would change the regulatory and labeled-warning sections.
• Posted results or peer-reviewed reports from the registered tirzepatide and incretin-background studies would change the narrow combination boundary.

Sources and records

• WADA — 2026 Prohibited List

• FDA GSRS/UNII record for eloralintide — U.S. Food and Drug Administration
• Drugs@FDA exact-active-ingredient API search for eloralintide — U.S. Food and Drug Administration
• FDA novel-drug approvals for 2026 — U.S. Food and Drug Administration
• Eloralintide phase 2 randomized trial in adults with obesity or overweight — The Lancet
• Eloralintide phase 1 multiple-ascending randomized study — Diabetes, Obesity and Metabolism
• Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept — Molecular Metabolism
• NCT05295940: first-in-human eloralintide study — ClinicalTrials.gov
• NCT06230523: eloralintide phase 2 obesity study — ClinicalTrials.gov
• NCT07321886: eloralintide phase 3 obesity study — ClinicalTrials.gov
• NCT06916065: eloralintide and tirzepatide phase 1 study — ClinicalTrials.gov
• NCT06603571: eloralintide and tirzepatide phase 2 study — ClinicalTrials.gov
• NCT07392190: eloralintide on background weekly incretin therapy — ClinicalTrials.gov
• ClinicalTrials.gov intervention search for eloralintide or LY3841136 — ClinicalTrials.gov
• PubMed Title/Abstract search for eloralintide or LY3841136 — National Library of Medicine