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    Research 11 min readOct 25, 2026 Fact-checked

    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.

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    CoachLexi

    Last checked

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

    Key Takeaway

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

    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). 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, AMPLIFY-1).

    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). Three peer-reviewed trial reports have followed: single doses, 12 weeks of weekly dosing and a 48-week Phase 2 that reported 9.5% to 20.1% mean weight loss against 0.4% on placebo, on the efficacy estimand (Lilly). Our count across ClinicalTrials.gov searches for eloralintide and LY3841136 is 24 studies: 7 in Phase 3, 5 in Phase 2 and 12 in Phase 1. Our eloralintide guide covers the drug itself.

    Phase 3 trials

    Trial Planned size and population Doses Primary endpoint Start Primary completion Status
    ENLIGHTEN-1, 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 1,035; type 2 diabetes, BMI 27+ 4 doses or placebo Weight change, week 64 Dec 2025 Jan 2028 Recruiting
    ENLIGHTEN-3, 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 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 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 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 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). 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). 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 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 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 200 adults with type 2 diabetes Macupatide, eloralintide, both, or placebo Weight change, week 32 Oct 2025 Mar 2027 Active, not recruiting
    NCT07589608 400 adults without diabetes Macupatide, eloralintide at three doses, three pairings, or placebo Weight change, week 36 May 2026 Sep 2027 Recruiting
    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) and up to 23.3% for the top EloraTZP arm with diabetes (Lilly; our EloraTZP breakdown). Macupatide (LY3532226) is Lilly's long-acting GIP receptor agonist (Phase 1b paper). 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 covers the rival amylin programs.

    Phase 1 trials

    Trial Planned size and population Doses Primary endpoint Start Primary completion Status
    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 128 Japanese adults with obesity or overweight Alone, and with tirzepatide Serious adverse events Apr 2024 Nov 2025 Completed
    NCT06345066 96 adults with overweight or obesity Eloralintide or placebo, each with tirzepatide Safety Apr 2024 Sep 2025 Completed
    NCT06916065 188 adults with overweight or obesity Alone, and with tirzepatide Drug exposure, safety Apr 2025 Jan 2026 Completed
    NCT06916091 30 Chinese adults, studied in Singapore Single dose or placebo Safety Apr 2025 Sep 2025 Completed
    NCT07401862 36 adults with or without liver impairment Single dose Drug exposure Feb 2026 Mar 2027 Recruiting
    NCT07426380 28 adults with or without severe kidney impairment Single dose Drug exposure Feb 2026 Oct 2026 Active, not recruiting
    NCT07665879 115 adults with overweight or obesity Eloralintide or placebo Insulin sensitivity by clamp, week 24 Jun 2026 Aug 2027 Recruiting
    NCT07701083 58 healthy adults Single doses of two solutions Drug exposure Jul 2026 Oct 2026 Active, not recruiting
    NCT07738614 56 adults with obesity or overweight Four dose cohorts or placebo Gastric emptying Jul 2026 Dec 2026 Recruiting
    NCT07808060 34 women with obesity or overweight With a levonorgestrel and ethinyl estradiol pill Contraceptive drug levels Sep 2026 Jun 2027 Recruiting
    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), 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)
    November 6, 2025 Phase 2 results at ObesityWeek and in The Lancet (Lilly)
    December 15, 2025 ENLIGHTEN-2 opens as the first Phase 3 (NCT07282600); four more follow in February 2026
    September 30, 2026 EloraTZP Phase 2b presented at EASD (Lilly)
    October 19, 2026 AMPLIFY-1 and AMPLIFY-2 first posted on ClinicalTrials.gov (NCT07881432)
    November and December 2026 AMPLIFY-2, then AMPLIFY-1, due to start (NCT07881458)
    March and September 2027 Macupatide pairings reach primary completion (NCT07215559, NCT07589608)
    January to June 2028 ENLIGHTEN primary completions: ENLIGHTEN-2 in January; 1, 3 and 4 in March; 6 in June (NCT07392190)
    October 2029 AMPLIFY-1 and AMPLIFY-2 primary completion (NCT07881432)
    July 2030 ENLIGHTEN-1's prediabetes extension ends (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), 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)
    Combination Two drugs may share one dosage form when each contributes to the claimed effects (21 CFR 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 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). 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).

    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, Q1 2026 and Q2 2026 gave no eloralintide filing date, and third-quarter results come on October 29, 2026.

    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

    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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    CoachLexiResearch editorial

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