Eloralintide
Evidence: B+ — Meaningful Human EvidenceMetabolic / Weight Management
Key facts
- Research areaMetabolic / Weight Management
- Study records53 human
- Study-at-a-Glance1published summaries
Evidence Snapshot
What this grade covers
SC monotherapy -- Phase 1b and full 48-week Phase 2, both peer-reviewed and integrity-clear on direct database check, plus exact-subject selectivity data. No oral program exists. Combination-with-tirzepatide data is development-status only and does not contribute to this grade.
Regulatory Context
Eloralintide is investigational. No approval was identified in the verified searches used for this review in any jurisdiction. A Phase 3 monotherapy program and several label-expansion studies are underway; none have reported results. Separate trials studying eloralintide in combination with tirzepatide are also underway and are development-status only.
Research Takeaway
Eloralintide (LY3841136) is a long-acting, SELECTIVE amylin-receptor agonist peptide, showing 12-fold selectivity for the amylin receptor over the calcitonin receptor and 11-fold over AMY3R in human in vitro assays.
Evidence boundary: Selectivity data is in vitro/preclinical; pair with clinical AE data before drawing safety conclusions.
See all 5 evidence claims →Quick Summary
Eloralintide (LY3841136) is a long-acting, selective amylin-receptor agonist peptide developed by Eli Lilly. In a 48-week Phase 2 trial, it produced mean body-weight reductions of approximately 9% to 20% versus 0.4% with placebo in adults with obesity or overweight. Its receptor selectivity (12-fold over the calcitonin receptor) distinguishes it from dual amylin/calcitonin agonists and from Amycretin, a broader triple-receptor agonist. Eloralintide is investigational, with a Phase 3 monotherapy program underway; it is also being studied in combination with tirzepatide in separate, still-unpublished trials.
Mechanism & Research Overview
Eloralintide (LY3841136) is a long-acting, SELECTIVE amylin-receptor agonist, showing 12-fold selectivity for the amylin receptor over the calcitonin receptor and 11-fold over AMY3R in human in vitro assays. This selectivity distinguishes it from dual amylin/calcitonin (DACRA-like) agonists and from Amycretin, which engages the calcitonin receptor as well as GLP-1 and amylin receptors.
Mechanism pathway
Relationship-support labels describe the type and directness of the research available, not proof of safety or effectiveness. Indirectly supported, inferred and uncertain relationships are not equivalent to directly supported ones.
- CompoundEloralintide
- Directly supported (Directly supported relationship)Biological targetAmylin receptorReceptor
- Leads toPathwayCalcitonin & Amylin Signaling
Relationship details
- Eloralintide → Amylin receptor — Directly supportedEloralintide (LY3841136) is a long-acting, selective amylin-receptor agonist, showing 12-fold selectivity for the amylin receptor over the calcitonin receptor and 11-fold over AMY3R in human in vitro assays.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Eloralintide (LY3841136) is a long-acting, SELECTIVE amylin-receptor agonist peptide, showing 12-fold selectivity for the amylin receptor over the calcitonin receptor and 11-fold over AMY3R in human in vitro assays.
Does not establish
Evidence boundary: Selectivity data is in vitro/preclinical; pair with clinical AE data before drawing safety conclusions.
Supported
In a 48-week Phase 2 RCT, SC eloralintide monotherapy produced mean body-weight reductions of approximately 9% to 20% across dose/regimen arms, versus 0.4% with placebo, in adults with obesity or overweight plus at least one weight-related comorbidity, without diabetes.
Does not establish
Evidence boundary: Responder-rate percentages are not frozen -- do not author them until independently verified.
Supported
In a 12-week Phase 1b RCT, the most commonly reported adverse events with SC eloralintide were decreased appetite (19%), headache (12%), fatigue (11%), diarrhea (10%), nausea (8%), and vomiting (4%).
Does not establish
Evidence boundary: Injection-site-reaction, mood-related-event, and pulse-rate-decrease figures are not frozen -- do not author them as confirmed figures.
Supported
Eloralintide is pharmacologically distinct from cagrilintide and pramlintide (both less receptor-selective amylin-pathway agents) and from Amycretin/zenagamtide (a triple-receptor GLP-1/amylin/calcitonin agonist) -- eloralintide's own discovery pharmacology describes a favorable, though not directly head-to-head-tested, gastrointestinal tolerability profile relative to other amylin-pathway agents.
Does not establish
Evidence boundary: Do NOT publish a specific percentage comparison against cagrilintide -- only the qualitative statement is verified.
Supported
Eloralintide is investigational; no approval was identified in the verified searches used for this review in any jurisdiction. Separate trials studying eloralintide in combination with tirzepatide are underway and are development-status only -- no combination-trial result may be used to support a monotherapy claim.
Sources: A Phase 1, Open-Label, Single and Multiple Dose Study of Eloralintide, and Eloralintide With Tirzepatide; A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
The most common adverse events reported with SC eloralintide in its Phase 1b trial were decreased appetite, headache, fatigue, diarrhea, nausea, and vomiting -- generally mild-to-moderate. Injection-site-reaction, mood-event, and pulse-rate figures remain unconfirmed and are not published here.Safety Consideration
Eloralintide's own discovery pharmacology reports a qualitatively favorable gastrointestinal tolerability profile compared to other amylin-pathway agents, based on receptor selectivity; this has not been confirmed in a head-to-head clinical trial and no specific percentage comparison is verified.Safety Consideration
Eloralintide has been studied in combination with tirzepatide in ongoing trials; no combination-specific safety conclusion can be drawn yet, and any future combination-trial safety finding must not be applied to eloralintide monotherapy.
Research Areas Being Studied
Research areas discussed on this page reflect the Metabolic / Weight Management category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
Show findings from 3 human studies
- Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept (2026):
- Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept (2025):
- Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial (2025):
Study Tables by Evidence Type
5 study records · 1 with a Study-at-a-Glance summary
Human Studies & Clinical Data(3)
Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial
2025NCT06230523 · PMID 41207310 · DOI 10.1016/S0140-6736(25)02155-5
Study-at-a-Glance available
- Population / Model
- 263 adults with obesity/overweight plus at least one weight-related comorbidity, non-diabetic, 46 US centers
- Dose / Duration / Finding
Mean body-weight reductions of approximately 9% to 20% across dose/regimen arms vs 0.4% with placebo; all arms met the primary endpoint. Favorable cardiometabolic secondary effects (waist circumference, blood pressure, lipids, glycemic markers, inflammation). Responder-rate percentages (e.g. proportion achieving >=20% weight loss) were reported in Stage 2A discovery but could not be independently confirmed from accessible abstract text.
Show full finding- Study/Trial Dosing:
- SC eloralintide, fixed doses 1/3/6/9mg and two dose-escalation schedules, once weekly, vs placebo
- Duration:
- 48 weeks
Safety note
Nausea and fatigue most common adverse events, mild-to-moderate, dose-related; low-dose arms approximately placebo-level.
Key takeaway
In this 48-week trial of 263 US adults with obesity or overweight, weekly eloralintide lowered body weight by about 9% to 20%, depending on dose, versus 0.4% with placebo. Nausea and fatigue were the most common side effects.
Study at a Glance
Study at a Glance
Plain-language summary of: Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial
How much weight did different doses of eloralintide help adults lose over 48 weeks?
Evidence status
What was being studied?
How much weight adults with obesity or overweight lost over 48 weeks on different once-weekly doses and dose-increase schedules of eloralintide, an experimental drug that acts on the amylin receptor (amylin is a hormone that helps control appetite), compared with placebo.
Who participated?
263 adults aged 18 to 75 at 46 US research centres, with a body-mass index of at least 30, or at least 27 with a weight-related health condition, and without type 2 diabetes. They were assigned to placebo (53) or to eloralintide 1 mg (28), 3 mg (24), 6 mg (28), 9 mg (54), a 6 mg then 9 mg schedule (24) or a 3 mg, 6 mg then 9 mg schedule (52). The average age was about 49, the average weight 109 kg, 204 (78%) were women and 205 (78%) were White.
How was the study done?
A Phase 2, randomized, double-blind, placebo-controlled trial. Participants injected placebo or eloralintide under the skin once a week for 48 weeks, either at a fixed dose or with the dose stepped up (6 mg for 20 weeks then 9 mg, or 3 mg for 4 weeks, 6 mg for 4 weeks, then 9 mg). The main measure was the percentage change in body weight from the start to week 48 in everyone randomized. This summary uses the ClinicalTrials.gov record with posted results and the journal abstract; the full paper was not reviewed.
Key results
Average body weight changed by -9.4% (1 mg), -12.4% (3 mg), -17.6% (6 mg), -20.1% (9 mg), -19.9% (6 mg then 9 mg) and -16.5% (3, 6 then 9 mg), compared with -0.4% on placebo (registry least-squares means at week 48; the journal abstract reports the same pattern as about -9%, -12%, -18%, -20%, -20% and -16% versus -0.4%). Model-based estimates of the share of people losing at least 10% of body weight were 12.9% on placebo and between 53.3% (1 mg) and 91.1% (6 mg then 9 mg) on eloralintide. Fewer people finished the trial on placebo (38 of 53) and on 1 mg (15 of 28) than on the higher-dose groups.
| Measure | Group | Timepoint | Reported value |
|---|---|---|---|
| Change in body weight, % from baseline (primary endpoint) | Placebo (n=53) | Week 48 | -0.4% (SE 0.91) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 1 mg weekly (n=28) | Week 48 | -9.4% (SE 1.60) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 3 mg weekly (n=24) | Week 48 | -12.4% (SE 1.30) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 6 mg weekly (n=28) | Week 48 | -17.6% (SE 1.56) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 9 mg weekly (n=54) | Week 48 | -20.1% (SE 1.31) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 6 mg for 20 weeks then 9 mg (n=24) | Week 48 | -19.9% (SE 1.45) |
| Change in body weight, % from baseline (primary endpoint) | Eloralintide 3 mg, then 6 mg, then 9 mg (n=52) | Week 48 | -16.5% (SE 1.18) |
| Share losing at least 5% of body weight (model-based estimate) | Placebo / 1 / 3 / 6 / 9 mg / 6-9 mg / 3-6-9 mg | Week 48 | 31.2% / 71.6% / 87.1% / 85.0% / 92.7% / 97.5% / 90.8%Estimated with a logistic regression model and multiple imputation for missing data. |
| Share losing at least 10% of body weight (model-based estimate) | Placebo / 1 / 3 / 6 / 9 mg / 6-9 mg / 3-6-9 mg | Week 48 | 12.9% / 53.3% / 60.5% / 76.6% / 82.3% / 91.1% / 79.2%Estimated with a logistic regression model and multiple imputation for missing data. |
What does this mean?
Safety findings
No deaths were reported. Serious adverse events occurred in 3 of 53 people on placebo and in 3 of 28 (1 mg), 1 of 24 (3 mg), 1 of 28 (6 mg), 3 of 54 (9 mg), 2 of 24 (6 then 9 mg) and 1 of 52 (3, 6 then 9 mg) on eloralintide; most were single events, including one case each of Guillain-Barre syndrome (9 mg) and multiple sclerosis (6 mg), and one serious report of suicidal ideation (1 mg). Nausea was reported by 7 of 53 on placebo and 3, 3, 18, 18, 13 and 13 on the eloralintide groups in the order above; fatigue by 6 of 53 on placebo and 0, 3, 8, 23, 11 and 11; vomiting by none on placebo and 7 on 6 mg. Hair loss (alopecia) was reported by 6 of 54 on 9 mg and none on placebo. Stopping because of an adverse event occurred in 2 people on placebo and 0 to 2 per eloralintide group. The journal abstract names nausea and fatigue as the most common adverse events.
Important limitations
- A Phase 2 trial of 48 weeks; it does not show long-term weight loss, weight regain after stopping, or effects on health outcomes.
- The dose groups were small and unequal (24 to 54 people), and participants were all in the United States, mostly women (78%) and White (78%), without type 2 diabetes.
- Many people left the trial early, especially on placebo (15 of 53 did not complete) and on 1 mg (13 of 28); percentages of people reaching weight-loss targets were estimated with a statistical model that fills in missing data.
- The registry reports least-squares means from a repeated-measures model, while the journal abstract reports the efficacy estimand with confidence intervals, so figures are close but not identical in presentation.
- No comparison with an approved weight-loss drug was made, and the trial was funded by the drug's developer.
- Only the journal abstract was reviewed, not the full paper.
Regulatory context
- Investigational use studied here
- Eloralintide (sponsor code LY3841136) was studied as an investigational treatment for obesity and overweight.
A search of Drugs@FDA for eloralintide (accessed 2026-10-08) found no application or approved product. No approval is implied.
Sources
- Trial record
- ClinicalTrials.gov NCT06230523 — ClinicalTrials.gov
- Primary results source
- The Lancet 2025, eloralintide 48-week phase 2 report (PubMed abstract) (peer-reviewed primary report; only the abstract was reviewed) — PubMedThe registry title uses the sponsor code LY3841136; the registry's arms and the journal use the name eloralintide. Group-level figures here come from ClinicalTrials.gov.
- Sources reviewed
- Trial registry record with posted results · Abstract only — full text not reviewed.
Other sources for this study (1)
- FDA Drugs@FDA search for eloralintide (accessed 2026-10-08) — Regulator (FDA / EMA) · No FDA application or approved product was found.Content reviewed for this summary
This summary is a plain-language reading aid written by MitoCore. It does not replace the original study, which remains the authoritative source. Research information only, not medical advice.
Eloralintide, a selective, long-acting amylin receptor agonist for treatment of obesity: Phase 1 proof of concept
2026PMID 41559929 · DOI 10.1111/dom.70439
- Population / Model
- 100 adults with obesity or overweight, 3 US sites
- Dose / Duration / Finding
Placebo-adjusted weight loss of 2.6%-11.3%, dose-dependent. Dose-proportional pharmacokinetics (AUC and Cmax ratios of dose-normalised geometric means of 1.1 and 1.0 at week 12); no absolute numeric half-life, Tmax, or Cmax values independently confirmed.
- Study/Trial Dosing:
- SC eloralintide, 5 dose cohorts (1.2/3/6/12mg) once weekly
- Duration:
- 12-week treatment + 10-week follow-up
Safety note
Decreased appetite 19%, headache 12%, fatigue 11%, diarrhea 10%, nausea 8%, vomiting 4% -- directly confirmed. Injection-site reactions (13%), mood-related events (n=4), and pulse-rate decrease (-14.4bpm at 12mg) were reported in Stage 2A discovery but could NOT be independently confirmed from accessible abstract text -- do not publish these three figures as confirmed until a full-text pull verifies them. 78% completion; 13 discontinued for adverse events.
Eloralintide (LY3841136), a novel amylin receptor agonist for the treatment of obesity: From discovery to clinical proof of concept
2025PMID 41109426 · DOI 10.1016/j.molmet.2025.102271
- Population / Model
- In vitro human/rat receptor assays; in vivo rat/monkey; Phase 1 human cohort of 48 healthy participants
- Dose / Duration / Finding
Eloralintide shows 12-fold selectivity for the amylin receptor over the calcitonin receptor and 11-fold over AMY3R in human in vitro assays -- a SELECTIVE amylin-receptor agonist, distinct from dual amylin/calcitonin (DACRA-like) pharmacology. In the human Phase 1 cohort, week-4 weight reduction was 2.5% (4mg) and 4.4% (12mg) vs placebo. Qualitatively described as having fewer gastrointestinal side effects compared to other amylin agonists; this is a qualitative statement only -- a specific quantitative comparator percentage against cagrilintide could not be independently verified in accessible full text and must not be published as a specific number.
Show full finding- Study/Trial Dosing:
- SC eloralintide, single doses 4mg/12mg (human Phase 1 cohort)
- Duration:
- Week 4 (human Phase 1 cohort)
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries(2)
A Phase 1, Open-Label, Single and Multiple Dose Study of Eloralintide, and Eloralintide With Tirzepatide
2026NCT06916065
- Population / Model
- 188 participants, 6 cohorts (A-D combination, E-F eloralintide-monotherapy)
- Dose / Duration / Finding
Development-status only. Contains genuine eloralintide-monotherapy arms (Cohorts E-F) alongside combination arms, but no results have been posted. Any future combination-arm result must not be used to support an eloralintide monotherapy claim.
- Study/Trial Dosing:
- SC eloralintide alone and SC eloralintide with tirzepatide
- Duration:
- Completed Jan 19, 2026; no results posted
A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide
2026NCT06603571
- Population / Model
- T2D and obesity/overweight population, 10 arms (3 LY3841136-monotherapy doses, combination arms, tirzepatide-monotherapy, placebo)
- Dose / Duration / Finding
Development-status only, distinct from the Phase 1 combination PK study (NCT06916065). No results posted. Any future combination-arm result must not be used to support an eloralintide monotherapy claim, and no tirzepatide-arm data from this trial may be used to describe eloralintide.
Show full finding- Study/Trial Dosing:
- SC eloralintide alone, SC eloralintide with tirzepatide, and tirzepatide alone
- Duration:
- Active, not recruiting; primary completion estimated Jul 2026; no results posted
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published research and does not provide medical advice, a recommendation, or instructions for human use.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
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