Investigational — Not FDA-Approved Authoritative Evidence Reference Phase 3 clinical trials (started 2026)

Eloralintide (LY3841136)

Once-weekly selective amylin receptor agonist (LY3841136, Eli Lilly); phase 3 ENLIGHTEN programme started in 2026; not approved.

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Drug Class Selective amylin receptor agonist: in laboratory assays it preferentially activates the human amylin 1 receptor (AMY1R) over the calcitonin receptor and the amylin 3 receptor.
FDA Regulatory Status Investigational — Not FDA-Approved
Clinical Stage Phase 3 clinical trials (started 2026)
Evidence Verification Active Reference Standards
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60-Second Scientific Briefing

Eloralintide (LY3841136) is an investigational once-weekly peptide from Eli Lilly that selectively activates the amylin 1 receptor. It is not approved anywhere; phase 3 trials (ENLIGHTEN) started in 2026. In a 48-week phase 2 trial (Lancet 2025, 263 adults with obesity) mean weight change ranged from −9% to −20% across dose groups, against −0.4% with placebo; nausea and fatigue were the most common adverse events.

What is Eloralintide?

Pharmacological Classification & Molecular Identity

Eloralintide (LY3841136) is an investigational once-weekly injectable peptide from Eli Lilly that activates the amylin receptor, studied for the treatment of obesity. [1] The Lancet, 2025 ↗

Verified Chemical & Regulatory Registry Identifiers

Documented Aliases & Research Codes:
LY3841136

Mechanism of Action & Receptor Targets

Biological Pathway and Target Binding

Receptor Selectivity: In cell assays eloralintide activated the human amylin 1 receptor about 12-fold more than the calcitonin receptor and 11-fold more than the amylin 3 receptor. Amylin receptor activation promotes satiety. In rats it caused less conditioned taste avoidance than the non-selective agonist cagrilintide. [1] Mol Metab, 2025 ↗

Regulatory & FDA Approval Status

Legal and Regulatory Classifications
⚠️ STRICT REGULATORY NOTICE: UNAPPROVED INVESTIGATIONAL DRUG

Investigational and not approved by the US FDA or any other regulator. Phase 3 trials started in 2026 (ENLIGHTEN-1, NCT07321886, from February 2026). [1] ClinicalTrials.gov, 2026 ↗

Eloralintide is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.

Human Evidence & Clinical Trials

Clinical Study Readouts and Evidence Syntheses

Phase 1 (Mol Metab 2025): single ascending doses in 48 healthy participants; once-weekly dosing was supported by the pharmacokinetics, and weight fell at 4 weeks after single doses. Phase 2 (Lancet 2025): 263 adults with obesity (mean BMI 39.1) randomised to six eloralintide dose regimens or placebo for 48 weeks; mean weight change ranged from −9% at the lowest dose to −20% at the highest dose regimens, vs −0.4% with placebo. [1] The Lancet, 2025 ↗ [2] Mol Metab, 2025 ↗

Clinical Evidence

Phase 1 (Mol Metab 2025): single ascending doses in 48 healthy participants; once-weekly dosing was supported by the pharmacokinetics, and weight fell at 4 weeks after single doses. Phase 2 (Lancet 2025): 263 adults with obesity (mean BMI 39.1) randomised to six eloralintide dose regimens or placebo for 48 weeks; mean weight change ranged from −9% at the lowest dose to −20% at the highest dose regimens, vs −0.4% with placebo.

Safety Profile & Clinical Limitations

Documented Adverse Events and Known Uncertainties

In the phase 2 trial the most common adverse events were nausea (11–64% across eloralintide groups vs 14% with placebo) and fatigue (0–46% vs 12%). In phase 1, 16 adverse events were reported by 9 participants on eloralintide, 15 of them mild. [1] The Lancet, 2025 ↗ [2] Mol Metab, 2025 ↗

ℹ️ Active Research Safety Surveillance

Phase 3 efficacy and safety, long-term effects and cardiovascular outcomes are unknown; the phase 2 trial included 263 people for 48 weeks. [1] The Lancet, 2025 ↗

Dose Approval Status

Commercial Dosing Status and Policy Directives
🛑 NO APPROVED COMMERCIAL DOSING REGIMEN

No dose is approved. The dose groups used in the trials are part of each trial's design and are described in the linked publications; they are not a recommendation. [1] ClinicalTrials.gov, 2026 ↗

Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.

Storage & Handling Status: There is no approved product label, so no official storage instructions exist outside the clinical trials, where the sponsor supplies the investigational product and its storage conditions.

What is Known vs. What is Unknown

Evidence Comparison and Clinical Evidence Boundaries

✓ Confirmed Scientific Evidence

  • Eloralintide (LY3841136) is an investigational once-weekly injectable peptide from Eli Lilly that activates the amylin receptor, studied for the treatment of obesity.
  • Targets & Selectivity: In cell assays eloralintide activated the human amylin 1 receptor about 12-fold more than the calcitonin receptor and 11-fold more than the amylin 3 receptor. Amylin receptor activation promotes satiety. In rats it caused less conditioned taste avoidance than the non-selective agonist cagrilintide.
  • Phase 1 (Mol Metab 2025): single ascending doses in 48 healthy participants; once-weekly dosing was supported by the pharmacokinetics, and weight fell at 4 weeks after single doses. Phase 2 (Lancet 2025): 263 adults with obesity (mean BMI 39.1) randomised to six eloralintide dose regimens or placebo for 48 weeks; mean weight change ranged from −9% at the lowest dose to −20% at the highest dose regimens, vs −0.4% with placebo.
  • Safety considerations: In the phase 2 trial the most common adverse events were nausea (11–64% across eloralintide groups vs 14% with placebo) and fatigue (0–46% vs 12%). In phase 1, 16 adverse events were reported by 9 participants on eloralintide, 15 of them mild.

? Unknown / Under Ongoing Investigation

  • Phase 3 efficacy and safety, long-term effects and cardiovascular outcomes are unknown; the phase 2 trial included 263 people for 48 weeks.

Verified Questions & Answers

10 Verified scientific answers with permanent anchor keys
#1

What is Eloralintide and how is it classified?

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Direct Answer

Eloralintide (LY3841136) is an investigational once-weekly injectable peptide from Eli Lilly that selectively activates the amylin 1 receptor, studied for obesity.

#2

What is the mechanism of action and receptor profile of Eloralintide?

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Direct Answer

It activates the amylin 1 receptor, which promotes satiety. In cell assays it was about 12-fold more active there than at the calcitonin receptor and 11-fold more than at the amylin 3 receptor.

#3

Is Eloralintide approved by the US FDA or health authorities?

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Direct Answer

No. Eloralintide is investigational and not approved anywhere. Phase 3 trials started in 2026.

#4

What human clinical evidence and trials exist for Eloralintide?

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Direct Answer

Phase 2 (Lancet 2025): 263 adults with obesity for 48 weeks; mean weight change from −9% to −20% across dose groups vs −0.4% with placebo. Phase 3 trials started in 2026.

Phase 1 (Mol Metab 2025): a randomised, placebo-controlled single-ascending-dose study in 48 healthy participants (mean BMI 27.5); the pharmacokinetics supported once-weekly dosing, and weight fell at week 4 after single doses compared with placebo. Phase 2 (Lancet 2025): 263 adults with obesity or overweight (mean weight 109.1 kg, mean BMI 39.1, 78% women) were randomised to six eloralintide dose regimens or placebo for 48 weeks; mean weight change ranged from −9% with the lowest dose to −20% with the highest dose regimens, against −0.4% with placebo. Phase 3: ENLIGHTEN-1 (NCT07321886) started in February 2026.

#5

What adverse effects and safety risks are documented for Eloralintide?

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Direct Answer

In phase 2 the most common adverse events were nausea (11–64% across eloralintide groups vs 14% with placebo) and fatigue (0–46% vs 12%). In phase 1, most adverse events were mild.

#6

What are the critical unknown safety aspects and clinical limitations of Eloralintide?

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Direct Answer

Phase 3 efficacy and safety, long-term effects and cardiovascular outcomes are not known yet; the phase 2 trial included 263 people for 48 weeks.

#7

What is the approved dosing status for Eloralintide?

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Direct Answer

No dose is approved. The trial dose groups are part of each trial's design and are described in the linked publications; they are not a recommendation.

#8

What are the storage and handling requirements for Eloralintide?

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Direct Answer

There is no approved product label, so no official storage instructions exist outside the clinical trials, where the sponsor supplies the investigational product and its storage conditions.

#9

Is Eloralintide prohibited in competitive sports by WADA?

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Direct Answer

It is not named individually on the 2026 WADA Prohibited List. Under section S0 (non-approved substances), any pharmacological substance without a current approval by a government health authority for human therapeutic use is prohibited at all times, so the investigational compound falls under S0 until it is approved. Athletes should confirm with their national anti-doping organisation.

Authoritative Citations:
#10

What is Egypt Peptides' official medical policy regarding Eloralintide?

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Direct Answer

Egypt Peptides publishes reviewed scientific reference monographs for documentation and research. The site does not give individual medical advice, preparation or injection instructions, combination protocols or off-label use instructions. Decisions about any medicine belong to the treating physician.

Authoritative Sources & Literature Registry

Regulatory dossiers, clinical trial registries, and published studies
Source [1] Tier 1 Regulatory / Academic

ENLIGHTEN-1: eloralintide in participants with obesity, or overweight without type 2 diabetes (phase 3) ↗

Publisher / Registry: ClinicalTrials.gov Publication Date: 2026-02-06 Trial ID: NCT07321886
Verified Locator: https://clinicaltrials.gov/study/NCT07321886
Source [2] Tier 1 Regulatory / Academic

Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2 randomised placebo-controlled trial ↗

Publisher / Registry: The Lancet Publication Date: 2025-12-06 PubMed PMID: 41207310
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/41207310/
Source [3] Tier 1 Regulatory / Academic

Eloralintide (LY3841136), a novel amylin receptor agonist: from discovery to clinical proof of concept (receptor selectivity compared with cagrilintide) ↗

Publisher / Registry: Mol Metab Publication Date: 2025-12-01 PubMed PMID: 41109426
Verified Locator: https://pubmed.ncbi.nlm.nih.gov/41109426/

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