---
title: "Eloralintide Clinical Trials: Phase 3 and Timeline"
url: https://www.bodyhackguide.co/blog/eloralintide-phase-3-trials
description: "Eloralintide Phase 3 trials with arms, endpoints, start and completion dates, plus a dated estimate of when a US approval decision could come."
lang: en
---

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Research 11 min read Oct 25, 2026 Fact-checked (https://www.bodyhackguide.co/editorial-standards)

# Eloralintide Clinical Trials: Phase 3 and Timeline

All 24 registered eloralintide trials: the five ENLIGHTEN Phase 3 studies, two EloraTZP trials, readout dates and what FDA approval would take.

C

CoachLexi

Last checked Oct 25, 2026

Evidence notes from published research and trial registries. Educational information, not medical advice.

Key Takeaway

**Eloralintide is still investigational, and on registry dates a US approval decision before 2029 looks unlikely.** Lilly's five Phase 3 ENLIGHTEN trials of eloralintide started between December 2025 and February 2026, plan 5,615 participants between them, and list their first primary completion for January 2028 (ENLIGHTEN-2 record (https://clinicaltrials.gov/study/NCT07282600)). Two Phase 3 trials of EloraTZP, eloralintide combined with tirzepatide, are due to open in November and December 2026 and list primary completion in October 2029 (AMPLIFY-2 (https://clinicaltrials.gov/study/NCT07881458), AMPLIFY-1 (https://clinicaltrials.gov/study/NCT07881432)).

Registry dates are sponsor estimates, and they slip. Everything on this page was checked against the registry, PubMed, Lilly and FDA on October 24, 2026.

## From first human dose to 24 studies

Lilly's first human study of eloralintide (LY3841136) started in March 2022 (NCT05295940 (https://clinicaltrials.gov/study/NCT05295940)). Three peer-reviewed trial reports have followed: single doses (https://doi.org/10.1016/j.molmet.2025.102271), 12 weeks of weekly dosing (https://pmc.ncbi.nlm.nih.gov/articles/PMC12992164/) and a 48-week Phase 2 (https://pubmed.ncbi.nlm.nih.gov/41207310/) that reported 9.5% to 20.1% mean weight loss against 0.4% on placebo, on the efficacy estimand (Lilly (https://www.prnewswire.com/news-releases/lillys-selective-amylin-agonist-eloralintide-demonstrated-meaningful-weight-loss-and-favorable-tolerability-in-a-phase-2-study-of-adults-with-obesity-or-overweight-302607061.html)). Our count across ClinicalTrials.gov searches for eloralintide (https://clinicaltrials.gov/search?intr=eloralintide) and LY3841136 (https://clinicaltrials.gov/search?term=LY3841136) is 24 studies: 7 in Phase 3, 5 in Phase 2 and 12 in Phase 1. Our eloralintide guide (https://www.bodyhackguide.co/compound/eloralintide) covers the drug itself.

## Phase 3 trials

| Trial | Planned size and population | Doses | Primary endpoint | Start | Primary completion | Status |
| --- | --- | --- | --- | --- | --- | --- |
| ENLIGHTEN-1, NCT07321886: https://clinicaltrials.gov/study/NCT07321886 | 1,980; obesity, or overweight with a related condition; no diabetes | 4 doses or placebo | Weight change, week 64 | Feb 2026 | Mar 2028 | Recruiting |
| ENLIGHTEN-2, NCT07282600: https://clinicaltrials.gov/study/NCT07282600 | 1,035; type 2 diabetes, BMI 27+ | 4 doses or placebo | Weight change, week 64 | Dec 2025 | Jan 2028 | Recruiting |
| ENLIGHTEN-3, NCT07369011: https://clinicaltrials.gov/study/NCT07369011 | 800; moderate to severe sleep apnea, BMI 27+, no diabetes | Eloralintide or placebo, by PAP use | Weight change and apnea-hypopnea index, week 64 | Feb 2026 | Mar 2028 | Recruiting |
| ENLIGHTEN-4, NCT07353931: https://clinicaltrials.gov/study/NCT07353931 | 900; knee osteoarthritis pain, BMI 27+, no diabetes | Eloralintide or placebo | Weight change and WOMAC pain, week 64 | Feb 2026 | Mar 2028 | Recruiting |
| ENLIGHTEN-6, NCT07392190: https://clinicaltrials.gov/study/NCT07392190 | 900; persistent obesity or overweight on a weekly incretin | 4 doses or placebo, added to the incretin | Weight change, week 64 | Feb 2026 | Jun 2028 | Recruiting |
| AMPLIFY-1, NCT07881432: https://clinicaltrials.gov/study/NCT07881432 | 2,115; BMI 35+, no diabetes | 5 EloraTZP doses, tirzepatide, eloralintide or placebo | Weight change, week 100 | Dec 2026, planned | Oct 2029 | Not open |
| AMPLIFY-2, NCT07881458: https://clinicaltrials.gov/study/NCT07881458 | 1,000; type 2 diabetes, BMI 27+ | EloraTZP or tirzepatide | Weight change, week 100 | Nov 2026, planned | Oct 2029 | Not open |

Weight change is percent change from baseline. No Phase 3 record gives milligram doses (see the FAQ). ENLIGHTEN-1 follows participants with prediabetes for two extra years, to July 2030, to time the onset of type 2 diabetes (NCT07321886 (https://clinicaltrials.gov/study/NCT07321886)). There is no ENLIGHTEN-5 on ClinicalTrials.gov; the numbering skips from 4 to 6.

ENLIGHTEN-3 and ENLIGHTEN-4 chase sleep apnea and knee pain claims, the route that earned Zepbound its sleep apnea approval (Lilly (https://www.prnewswire.com/news-releases/lillys-eloratzp-combination-of-eloralintide-and-tirzepatide-delivered-greater-weight-loss-and-a1c-reduction-vs-tirzepatide-15-mg-in-adults-with-obesity-and-type-2-diabetes-302894480.html)). We'd watch ENLIGHTEN-6 most closely. It adds eloralintide on top of a weekly incretin, which is how many people would meet an amylin drug.

## Phase 2 trials

| Trial | Planned size and population | Doses | Primary endpoint | Start | Primary completion | Status |
| --- | --- | --- | --- | --- | --- | --- |
| NCT06230523: https://clinicaltrials.gov/study/NCT06230523 | 263 US adults with obesity or overweight; no diabetes | 1, 3, 6 or 9 mg weekly; 6 then 9 mg; 3, 6, then 9 mg | Weight change, week 48 | Feb 2024 | May 2025 | Completed, results posted |
| NCT06603571: https://clinicaltrials.gov/study/NCT06603571 | 367 adults with type 2 diabetes | Eloralintide 3, 6 or 9 mg; tirzepatide 15 mg; four pairings; one add-on arm | Weight change, week 48 | Sep 2024 | Jul 2026 | Completed |
| NCT07215559: https://clinicaltrials.gov/study/NCT07215559 | 200 adults with type 2 diabetes | Macupatide, eloralintide, both, or placebo | Weight change, week 32 | Oct 2025 | Mar 2027 | Active, not recruiting |
| NCT07589608: https://clinicaltrials.gov/study/NCT07589608 | 400 adults without diabetes | Macupatide, eloralintide at three doses, three pairings, or placebo | Weight change, week 36 | May 2026 | Sep 2027 | Recruiting |
| NCT06143956: https://clinicaltrials.gov/study/NCT06143956 | Master protocol across several Lilly drugs, 1,481 | Umbrella for NCT06230523, NCT06603571 and NCT07589608 | Allocation to sub-studies | Nov 2023 | Sep 2027 | Recruiting |

Two have reported, both on the efficacy estimand: up to 20.1% without diabetes (our phase 2 review (https://www.bodyhackguide.co/blog/eloralintide-phase-2-results)) and up to 23.3% for the top EloraTZP arm with diabetes (Lilly (https://www.prnewswire.com/news-releases/lillys-eloratzp-combination-of-eloralintide-and-tirzepatide-delivered-greater-weight-loss-and-a1c-reduction-vs-tirzepatide-15-mg-in-adults-with-obesity-and-type-2-diabetes-302894480.html); our EloraTZP breakdown (https://www.bodyhackguide.co/blog/eloratzp-eloralintide-tirzepatide)). Macupatide (LY3532226) is Lilly's long-acting GIP receptor agonist (Phase 1b paper (https://pmc.ncbi.nlm.nih.gov/articles/PMC13341334/)). Its two Phase 2 trials with eloralintide are set up to test whether amylin plus GIP works without a GLP-1 drug; amylin analogs compared (https://www.bodyhackguide.co/blog/amylin-analogs-compared) covers the rival amylin programs.

## Phase 1 trials

| Trial | Planned size and population | Doses | Primary endpoint | Start | Primary completion | Status |
| --- | --- | --- | --- | --- | --- | --- |
| NCT05295940: https://clinicaltrials.gov/study/NCT05295940 | 148 healthy or overweight adults | Single doses 0.04 to 12 mg; 12 weekly doses of 1.2 to 12 mg | Safety | Mar 2022 | Jan 2024 | Completed, published |
| NCT06297616: https://clinicaltrials.gov/study/NCT06297616 | 128 Japanese adults with obesity or overweight | Alone, and with tirzepatide | Serious adverse events | Apr 2024 | Nov 2025 | Completed |
| NCT06345066: https://clinicaltrials.gov/study/NCT06345066 | 96 adults with overweight or obesity | Eloralintide or placebo, each with tirzepatide | Safety | Apr 2024 | Sep 2025 | Completed |
| NCT06916065: https://clinicaltrials.gov/study/NCT06916065 | 188 adults with overweight or obesity | Alone, and with tirzepatide | Drug exposure, safety | Apr 2025 | Jan 2026 | Completed |
| NCT06916091: https://clinicaltrials.gov/study/NCT06916091 | 30 Chinese adults, studied in Singapore | Single dose or placebo | Safety | Apr 2025 | Sep 2025 | Completed |
| NCT07401862: https://clinicaltrials.gov/study/NCT07401862 | 36 adults with or without liver impairment | Single dose | Drug exposure | Feb 2026 | Mar 2027 | Recruiting |
| NCT07426380: https://clinicaltrials.gov/study/NCT07426380 | 28 adults with or without severe kidney impairment | Single dose | Drug exposure | Feb 2026 | Oct 2026 | Active, not recruiting |
| NCT07665879: https://clinicaltrials.gov/study/NCT07665879 | 115 adults with overweight or obesity | Eloralintide or placebo | Insulin sensitivity by clamp, week 24 | Jun 2026 | Aug 2027 | Recruiting |
| NCT07701083: https://clinicaltrials.gov/study/NCT07701083 | 58 healthy adults | Single doses of two solutions | Drug exposure | Jul 2026 | Oct 2026 | Active, not recruiting |
| NCT07738614: https://clinicaltrials.gov/study/NCT07738614 | 56 adults with obesity or overweight | Four dose cohorts or placebo | Gastric emptying | Jul 2026 | Dec 2026 | Recruiting |
| NCT07808060: https://clinicaltrials.gov/study/NCT07808060 | 34 women with obesity or overweight | With a levonorgestrel and ethinyl estradiol pill | Contraceptive drug levels | Sep 2026 | Jun 2027 | Recruiting |
| NCT07765511: https://clinicaltrials.gov/study/NCT07765511 | 60 Japanese adults without diabetes | Macupatide, eloralintide, both, or placebo | Serious adverse events | Oct 2026, planned | Jun 2027 | Not open |

Most of this is the groundwork a drug label needs: liver and kidney exposure, a second solution, a pill interaction. NCT07738614 is the exception. The 12-week Phase 1 suggested any slowing of gastric emptying was brief, unlike with native amylin or pramlintide (Phase 1 paper (https://pmc.ncbi.nlm.nih.gov/articles/PMC12992164/)), and this study makes that its primary endpoint.

## Timeline: what has reported and what is due

| When | What |
| --- | --- |
| March 2022 | First human study starts (NCT05295940 (https://clinicaltrials.gov/study/NCT05295940)) |
| November 6, 2025 | Phase 2 results at ObesityWeek and in The Lancet (Lilly (https://www.prnewswire.com/news-releases/lillys-selective-amylin-agonist-eloralintide-demonstrated-meaningful-weight-loss-and-favorable-tolerability-in-a-phase-2-study-of-adults-with-obesity-or-overweight-302607061.html)) |
| December 15, 2025 | ENLIGHTEN-2 opens as the first Phase 3 (NCT07282600 (https://clinicaltrials.gov/study/NCT07282600)); four more follow in February 2026 |
| September 30, 2026 | EloraTZP Phase 2b presented at EASD (Lilly (https://www.prnewswire.com/news-releases/lillys-eloratzp-combination-of-eloralintide-and-tirzepatide-delivered-greater-weight-loss-and-a1c-reduction-vs-tirzepatide-15-mg-in-adults-with-obesity-and-type-2-diabetes-302894480.html)) |
| October 19, 2026 | AMPLIFY-1 and AMPLIFY-2 first posted on ClinicalTrials.gov (NCT07881432 (https://clinicaltrials.gov/study/NCT07881432)) |
| November and December 2026 | AMPLIFY-2, then AMPLIFY-1, due to start (NCT07881458 (https://clinicaltrials.gov/study/NCT07881458)) |
| March and September 2027 | Macupatide pairings reach primary completion (NCT07215559 (https://clinicaltrials.gov/study/NCT07215559), NCT07589608 (https://clinicaltrials.gov/study/NCT07589608)) |
| January to June 2028 | ENLIGHTEN primary completions: ENLIGHTEN-2 in January; 1, 3 and 4 in March; 6 in June (NCT07392190 (https://clinicaltrials.gov/study/NCT07392190)) |
| October 2029 | AMPLIFY-1 and AMPLIFY-2 primary completion (NCT07881432 (https://clinicaltrials.gov/study/NCT07881432)) |
| July 2030 | ENLIGHTEN-1's prediabetes extension ends (NCT07321886 (https://clinicaltrials.gov/study/NCT07321886)) |

## What approval would require

| Requirement | What FDA asks | Where eloralintide stands |
| --- | --- | --- |
| Efficacy | Mean weight loss at least 5 points better than control after a year at the maintenance dose, with statistical significance | Phase 2's best arm: 20.1% against 0.4% (Lancet (https://pubmed.ncbi.nlm.nih.gov/41207310/)), on the efficacy estimand; treatment-policy figures are likely to run lower |
| Safety exposure | About 3,000 people on the drug in the intended dose range and at least 1,500 on placebo, for a year or more | ENLIGHTEN plans 5,615 participants in all, our sum of registry targets; the drug-to-placebo split is not posted |
| Heart | A full cardiovascular assessment with ambulatory blood pressure monitoring, and possibly an outcomes trial if a risk signal appears | No outcomes trial registered; Phase 1 saw pulse fall 14.4 beats per minute on 12 mg (Phase 1 paper (https://pmc.ncbi.nlm.nih.gov/articles/PMC12992164/)) |
| Combination | Two drugs may share one dosage form when each contributes to the claimed effects (21 CFR 300.50 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-300/subpart-B/section-300.50)) | AMPLIFY-1's eloralintide-only, tirzepatide-only and placebo arms are how a sponsor shows that |

Source for the first three rows: FDA's January 2025 draft guidance (https://www.fda.gov/media/71252/download) for weight-reduction drugs.

FDA aims to act on a standard application for a new molecular entity within 10 months of the 60-day filing date, or 6 months under priority review (PDUFA VII goals (https://www.fda.gov/media/151712/download)). The Commissioner's National Priority Voucher pilot targets about two months, and Lilly's Foundayo was approved 50 days after filing in April 2026 (FDA (https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program)).

## The release date estimate, spelled out

This arithmetic is ours, not Lilly's. ENLIGHTEN-1 and ENLIGHTEN-2 plan 3,015 participants, short of FDA's safety exposure on their own, so a filing probably waits for more readouts between March and June 2028. A filing in the second half of 2028 and a standard review would put a decision in 2029. A voucher-speed review could bring it to late 2028, but we found no public record of a voucher for eloralintide. EloraTZP cannot be filed before AMPLIFY reports, which points to 2030 or later. Lilly's earnings releases for Q4 2025 (https://www.prnewswire.com/news-releases/lilly-reports-fourth-quarter-2025-financial-results-and-provides-2026-guidance-302678376.html), Q1 2026 (https://www.prnewswire.com/news-releases/lilly-reports-first-quarter-2026-financial-results-raises-full-year-guidance-and-highlights-momentum-of-new-medicines-302758113.html) and Q2 2026 (https://www.prnewswire.com/news-releases/lilly-reports-second-quarter-2026-financial-results-raises-full-year-guidance-and-highlights-continued-growth-and-pipeline-progress-302843165.html) gave no eloralintide filing date, and third-quarter results come on October 29, 2026 (https://www.prnewswire.com/news-releases/lilly-confirms-date-and-conference-call-for-third-quarter-2026-financial-results-announcement-302909019.html).

## Blanks we couldn't fill

- The milligram doses in every Phase 3 arm.
- How many ENLIGHTEN readouts Lilly waits for before filing.
- What, if anything, ENLIGHTEN-5 is.
- Treatment-policy results, confidence intervals and a peer-reviewed paper for the EloraTZP Phase 2b.
- Long-term safety, rare harms and what happens to weight after stopping.

## Sources and related pages

- ClinicalTrials.gov eloralintide records: https://clinicaltrials.gov/search?intr=eloralintide
- Lilly: Phase 2 results, November 6, 2025 (https://www.prnewswire.com/news-releases/lillys-selective-amylin-agonist-eloralintide-demonstrated-meaningful-weight-loss-and-favorable-tolerability-in-a-phase-2-study-of-adults-with-obesity-or-overweight-302607061.html), EloraTZP Phase 2b, September 30, 2026 (https://www.prnewswire.com/news-releases/lillys-eloratzp-combination-of-eloralintide-and-tirzepatide-delivered-greater-weight-loss-and-a1c-reduction-vs-tirzepatide-15-mg-in-adults-with-obesity-and-type-2-diabetes-302894480.html)
- Papers: Phase 2 (https://pubmed.ncbi.nlm.nih.gov/41207310/), Phase 1 multiple dose (https://pmc.ncbi.nlm.nih.gov/articles/PMC12992164/), discovery (https://doi.org/10.1016/j.molmet.2025.102271), macupatide Phase 1b (https://pmc.ncbi.nlm.nih.gov/articles/PMC13341334/)
- FDA: weight-reduction draft guidance (https://www.fda.gov/media/71252/download), PDUFA VII goals (https://www.fda.gov/media/151712/download), 21 CFR 300.50 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-300/subpart-B/section-300.50), Foundayo voucher approval (https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program)
- EloraTZP trial results (https://www.bodyhackguide.co/blog/eloratzp-eloralintide-tirzepatide) and eloralintide phase 2 results (https://www.bodyhackguide.co/blog/eloralintide-phase-2-results)

## Frequently asked

Not before its Phase 3 trials report, and the first is due to finish its main measurements in January 2028. A US decision before 2029 looks unlikely; late 2028 would take a voucher-speed review, and we found no public record of a voucher for eloralintide. Both dates are our estimates from the registry, not company guidance.

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