Eloralintide (LY3841136) (10mg)
Eloralintide (LY3841136, Eli Lilly) is a selective amylin receptor agonist undergoing clinical development. It is not an approved medication. This page summarizes bibliographic data from Phase 1–3 studies and reference laboratory mathematics for a hypothetical 10 mg vial.
Reviewed by the AllPeptides.eu Editorial Team·Last reviewed: 2026-06-16
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
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How It Works
Eloralintide is a selective amylin receptor agonist. In in vitro data from the NCT05295940 publication, it preferentially activated the human AMY1R, with 12-fold selectivity over CTR and 11-fold selectivity over AMY3R. In preclinical data, it caused less conditioned taste avoidance in lean rats than cagrilintide. The Phase 1 pharmacokinetic profile supported the study of once-weekly dosing in subsequent trials.
Quick Start
- Laboratory reconstitution reference: 3.0 mL bacteriostatic water → ~3.33 mg/mL concentration.
- Phase 2 NCT06230523: Arms of 1, 3, 6, and 9 mg once weekly, as well as 6–9 mg and 3–9 mg titration arms, for 48 weeks.
- Concentration mathematics: At 3.33 mg/mL, 1 unit = 0.01 mL ≈ 33.3 mcg on a U-100 scale.
- Regulatory status: Investigational molecule; Phase 3 results from ENLIGHTEN have not been published.
Phase 2 NCT06230523 Arms — reference mathematics (3 mL = ~3.33 mg/mL)
Route: Subcutaneously, as reported in clinical trials | Frequency: Once weekly in Phase 2 NCT06230523
| Week | Dose | Units (per injection) |
|---|---|---|
| NCT06230523 — 48 weeks | 1 mg arm | 30 Units (0.30 mL) |
| NCT06230523 — 48 weeks | 3 mg arm | 90 Units (0.90 mL) |
| NCT06230523 — 48 weeks | 6 mg arm | 2 × 90 Units (0.90 mL) |
| NCT06230523 — 48 weeks | 9 mg arm | 3 × 90 Units (0.90 mL) |
| NCT06230523 — titration | 6–9 mg arm | 180–270 Units (1.80–2.70 mL) |
| NCT06230523 — titration | 3–9 mg arm | 90–270 Units (0.90–2.70 mL) |
The table values represent arms reported in NCT06230523, not a recommendation or dosing schedule. The units and mL values are exclusively a mathematical conversion for a reference concentration of 10 mg / 3.0 mL.
Reconstitution Steps
- In a reference laboratory calculation, 3.0 mL bacteriostatic water corresponds to a concentration of ~3.33 mg/mL for a 10 mg vial.
- Gently add the diluent against the vial wall to limit foaming.
- Continue to gently rotate until the lyophilized material is fully dissolved.
- Storage conditions are determined by the investigational material's protocol and not by an approved product label.
- Cloudiness or particulates are grounds for discarding the investigational solution.
Protocol Overview
- Molecule: Eloralintide (LY3841136), a selective amylin receptor agonist from Eli Lilly.
- Regulatory status: Under clinical development; not an approved drug.
- Phase 1 NCT05295940: A total of 148 participants. Includes a single ascending dose part of 0.04–12 mg in 48 healthy participants (mean BMI 27.5) and a separate 12-week multiple weekly dose part in 100 participants with obesity or who were overweight.
- Phase 2 NCT06230523: 263 participants, 48 weeks, 46 centers in the US.
- Phase 3 ENLIGHTEN: Five registered studies with unpublished results.
- Laboratory reference: 3.0 mL per hypothetical 10 mg vial (~3.33 mg/mL).
Dosing Protocol
- Phase 1 NCT05295940: The publication reports single ascending doses of 0.04–12 mg.
- Phase 1 result: The 4 mg and 12 mg arms showed a mean change in body weight at week 4 of −2.5% and −4.4%, versus +0.6% with placebo.
- Phase 1 multiple dose (12 weeks): In a separate published part of weekly administration without titration, the mean change in body weight at week 12 ranged from −2.6% to −11.3% per arm, with minimal gastrointestinal adverse events (Diabetes Obes Metab 2026).
- Phase 2 NCT06230523: The publication reports weekly arms of 1, 3, 6, and 9 mg, as well as 6–9 mg and 3–9 mg titration.
- Phase 2 48-week result: −9% (1 mg), −12% (3 mg), −18% (6 mg), −20% (9 mg), −20% (6–9 mg), and −16% (3–9 mg), versus −0.4% with placebo.
- Interpretation: The above are published results of specific research arms and not usage instructions.
- Combination research: Registered studies are examining eloralintide in combination with macupatide (Phase 2/2b, NCT07589608 and NCT07215559) and with tirzepatide (Phase 2 NCT06603571, with preceding Phase 1 studies). There are no published results, and this does not constitute a recommendation for combination therapy.
- Break between cycles: A 2–4 week break is recommended before repeating the cycle.
Washout & Cycle Restart
When can I restart?
After completing the cycle, a 2–4 week break is recommended before starting a new cycle. This allows the body to restore normal function and prevents potential downregulation (tachyphylaxis).
Storage Instructions
- There is no approved product label with standardized storage conditions for eloralintide.
- Storage and stability conditions depend on the specific investigational material and the laboratory protocol.
Important Notes
- Eloralintide is an investigational molecule and is not approved by the FDA or EMA.
- Phase 1 and Phase 2 data have been published; the results of the Phase 3 ENLIGHTEN studies remain unpublished.
- The numerical values on this page exclusively represent the arms and results of the referenced trials.
Potential Benefits & Side Effects
Potential Benefits:
- Phase 2 NCT06230523: Dose-dependent change in body weight in the study arms at 48 weeks.
- Mean weight change: −9% (1 mg), −12% (3 mg), −18% (6 mg), −20% (9 mg), −20% (6–9 mg), and −16% (3–9 mg), versus −0.4% with placebo.
- Phase 1 NCT05295940: −2.5% and −4.4% at week 4 in the 4 mg and 12 mg arms, versus +0.6% with placebo.
- Investigational status: Phase 3 results require publication before confirmatory conclusions can be made.
Potential Side Effects:
- Nausea in NCT06230523: 11% (1 mg), 13% (3 mg), 64% (6 mg), 33% (9 mg), 54% (6–9 mg), and 25% (3–9 mg), versus 14% with placebo.
- Fatigue in NCT06230523: 0%, 13%, 29%, 43%, 46%, and 21% respectively, versus 12% with placebo.
- Phase 1 NCT05295940: 16 adverse events were reported in nine participants in the eloralintide arms; 15 of which were mild.
- Available safety data remains limited by the size and duration of the published trials.
⚠️ Serious Warnings & Long-Term Risks
The following warnings are based on published literature, FDA labels, and post-marketing surveillance. They do not constitute medical advice. Consult a healthcare professional.
Gastrointestinal tolerability under investigation
In Phase 2 NCT06230523, nausea rates varied substantially across research arms and reached up to 64%. The compound remains in clinical development.
📄 Lancet Phase 2 — NCT06230523References
- The Lancet (2025) — Eloralintide Phase 2, NCT06230523 — 48 weeks, 263 participants
View Source - Molecular Metabolism (2025) — Eloralintide Phase 1, NCT05295940 — from discovery to clinical proof-of-concept
View Source - Diabetes Obes Metab (2026) — Eloralintide Phase 1 multiple dose, 12 weeks — proof-of-concept (−2.6% to −11.3%)
View Source - Endocrinol Diabetes Metab (2026) — Network meta-analysis of amylin analogues — high-dose eloralintide ~−18% (indirect, preliminary)
View Source - ClinicalTrials.gov — ENLIGHTEN-1 — NCT07321886
View Source - ClinicalTrials.gov — ENLIGHTEN-2 — NCT07282600
View Source - ClinicalTrials.gov — ENLIGHTEN-3 — NCT07392190
View Source - ClinicalTrials.gov — ENLIGHTEN OSA — NCT07369011
View Source - ClinicalTrials.gov — ENLIGHTEN knee osteoarthritis — NCT07353931
View Source
External Sources & Regulatory Status
Regulatory Approvals
Research-only — not approved
Research-only — not approved
Research-only — Phase III ongoing, not approved
Educational information. Not medical advice, and no efficacy claim is implied. Regulatory approval is not a use recommendation by AllPeptides.eu.
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