Eloralintide

Study	Participants
Phase 1 single dose	48 · single-ascending-dose part
Phase 1 repeated dose	100 · multiple-ascending-dose part
Phase 2	263 · 48-week randomized cohort

How the studies connect

The two phase 1 papers describe separate groups within NCT05295940. The phase 2 paper and NCT06230523 report the same 263 participants.^{1613,1619,1620,1621,1622}

The 48-week phase 2 result

20%

The journal abstract reports a 20% mean reduction at week 48 in the fixed 9 mg and 6-to-9 mg groups, versus 0.4% with placebo. The registry gives model-based estimates of 20.1% and 19.9% for those active groups.^1620,1622

Published results and registry tables

The paper and registry follow the same 263 participants. The paper reports the peer-reviewed results; the registry provides group counts, study completion and outcome tables.^1620,1622

Follow-up periods

The main weight result is reported at week 48. The registry follows adverse events through week 58. Its safety tables use all-randomized group denominators, while the paper defines its safety population as participants who received at least one dose.^1620,1622

Reading the safety evidence

206 of 263

The registry reports 206 study completers among 263 randomized participants. Its participant-flow table lists adverse events as the reason for study noncompletion in six eloralintide participants and two placebo participants. Leaving the study is not the same measure as stopping treatment.^1622,1620

Nausea and fatigue varied by group

The published abstract reports nausea in 11% to 64% and fatigue in 0% to 46% across active groups. The posted registry tables provide the underlying all-randomized counts. Rates varied substantially between regimens.^1620,1622

Phase 1b safety observations

The 100-person repeated-dose report describes pulse changes and four participants with mood-related events. Its participants and 12-week treatment period differ from the phase 2 trial.¹⁶¹⁹

Phase 3 studies

5 trials

The five phase 3 records cover weight management with and without type 2 diabetes, obstructive sleep apnea, knee osteoarthritis pain and persistent obesity during weekly incretin treatment.^{1618,1624,1625,1626,1627}

Results are still pending

All five global records were recruiting and had no posted results in the cited snapshots. Their planned enrollment and outcomes describe study designs; they do not supply efficacy or safety results.^{1618,1624,1625,1626,1627}

Linked registry records

The dated registry union contains 22 matched global records, including combination studies and a shared master protocol. Regional registrations, master records and intervention-specific appendices can overlap those studies and should not be summed as new participant cohorts.^1637,1638

How it works

01 What is eloralintide?

Eloralintide is an experimental, long-acting amylin receptor agonist developed by Eli Lilly. Amylin is a hormone released with insulin after a meal and helps regulate appetite and fullness.¹⁶¹³

02 Is it a GLP-1 drug?

It acts through amylin receptors. GLP-1 and GIP are different hormone pathways; researchers are testing whether combining them with eloralintide adds benefit.^1613,1614

03 How is it different from cagrilintide?

Both act on the amylin receptor family. In human receptor assays, eloralintide was more potent at AMY1 than at the calcitonin receptor. The discovery paper compared eloralintide with cagrilintide in rats.¹⁶¹³

04 Does receptor selectivity make it free of nausea?

Nausea remained common in several phase 2 groups. The AMY1 preference describes receptor experiments; the human trial supplies the clinical side-effect data.^{1613,1620,1622}

05 How long does it stay in the body?

The single-dose human study measured a terminal half-life of 310 to 366 hours, or 12.9 to 15.3 days, across its 0.4 mg to 12 mg groups. Peak blood concentration occurred later than the injection, with median times of 72.0 to 132.2 hours across the studied doses.¹⁶¹³

Identity, approval and evidence status

01 Are LY3841136 and AMY-1176 the same compound?

ChEMBL and GSRS list LY3841136, LY-3841136, AMY1176 and AMY-1176 as eloralintide names or development codes.^1615,1616

02 Is eloralintide approved in the United States?

No matching approval record was located in the dated FDA name-and-code searches. The current trial records describe an investigational program, with phase 3 results still pending.^1617,1618

03 Does an FDA substance identifier mean the drug is approved?

GSRS assigns eloralintide the substance identifier 73G3354J8W. Substance registration identifies a chemical or biological material; medicinal-product approval is a separate regulatory record.^1616,1617

04 How many people are in the published primary studies?

The first phase 1 protocol included a 48-person single-dose part and a separate 100-person repeated-dose part. The published phase 2 study randomized 263 adults. The two phase 1 papers cover different parts of the same 148-person registry protocol.^{1613,1619,1620,1621}

05 Is there an approved dose?

The FDA searches located no matching approved product or label. Published studies used different single-dose, repeated-dose and escalation designs under trial supervision. Those designs describe the research record.^{1617,1613,1619,1620}

06 Why do some sources give different trial counts?

The current API searches returned 22 distinct global registry records, including combination studies and a shared master protocol. Six EU CTIS records and seven Japanese jRCT records map to studies in that set. Papers, regional registrations and separate study parts need to be counted by their actual participant groups.^{1637,1638,1621}

07 How independent is the evidence?

Eli Lilly sponsored the primary clinical studies and the 22 cited global registry protocols. The phase 2 paper includes external clinical investigators as well as Lilly employees, with conflicts of interest disclosed. The primary participant evidence comes from the sponsor's program.^{1613,1619,1620,1637}

08 Does a matching CAS number prove a separately sold material is the trial drug?

PubChem and GSRS both associate CAS 2883634-40-8 with eloralintide. Their formula and mass fields conflict, and GSRS itself flags structural-validation problems. Confirming the contents, concentration, purity and formulation of a particular sample requires evidence about that sample.^1639,1616

Human studies

01 Which groups reached about 20% weight loss?

The phase 2 paper reports a 20% mean reduction at week 48 in the fixed 9 mg group and the 6-to-9 mg group, versus 0.4% with placebo, using its efficacy estimand. The registry gives modeled estimates of 20.1% and 19.9% for those groups. Individual changes varied.^1620,1622

02 Who was in the 48-week weight-loss study?

The 263 participants were adults with obesity, or overweight with a weight-related condition, without type 2 diabetes. Their mean age was 49 years, mean weight was 109.1 kg and 204 were women. The study ran at 46 U.S. research centres.^1620,1622

03 Did every participant finish the phase 2 study?

The registry reports 206 study completers among 263 randomized participants. The primary weight analysis uses all 263 randomized participants with a statistical model for repeated measurements. Completion and inclusion in an analysis are different counts.¹⁶²²

04 Has it beaten tirzepatide or semaglutide in a direct human trial?

The published phase 2 monotherapy study compared eloralintide with placebo. Trials testing eloralintide and tirzepatide, alone or together, are registered, but the cited records have no posted results. Comparing percentages from separate trials leaves differences in participants, duration and analysis unresolved.^{1620,1614,1623}

05 What happened after the phase 1b treatment ended?

Treatment lasted 12 weeks. The 6 mg and 12 mg groups still had a statistically significant weight difference from placebo at week 21. The longer-term maintenance course remains an open question.¹⁶¹⁹

06 Does it preserve muscle while reducing fat?

The discovery study measured body composition in rats and reported less lean-mass loss than with cagrilintide. The accessible phase 2 abstract and posted outcome tables do not verify a human muscle-preservation result. A claimed human fat-loss proportion still needs the full article, supplement or another direct source.^{1613,1620,1622}

07 Can someone tell whether they received eloralintide or placebo?

The phase 2 trial was double-blind. A change in weight, appetite or side effects does not confirm an individual assignment. The published results compare the study groups after investigators can analyse their treatment assignments.^1620,1622

08 How soon does appetite or food noise change?

The phase 1b study measured appetite, hunger and fullness. It found a nonsignificant fasting-appetite trend and no clear dose- or time-related pattern after meals. A dependable timeline for an individual's change in food noise has not been established.¹⁶¹⁹

Safety, tolerability and study limits

01 How common was nausea?

The published phase 2 abstract reports nausea in 11% to 64% across active groups and 14% with placebo. In the registry's all-randomized table, the fixed 6 mg group had 18 affected participants out of 28, and the fixed 9 mg group had 18 out of 54. The paper's safety population required at least one treatment dose; the registry labels its denominator as all randomized participants.^1620,1622

02 Did gradually increasing the amount reliably prevent nausea?

Nausea did not follow a simple order across the phase 2 regimens. The registry reports 13 affected participants out of 24 in the 6-to-9 mg group and 13 out of 52 in the 3-to-6-to-9 mg group. These small groups used different regimens, leaving the reason for the difference unresolved.^1622,1620

03 Was vomiting reported?

The phase 2 registry reports vomiting in seven of 28 participants in the fixed 6 mg group, six of 54 in the fixed 9 mg group, four of 24 in the 6-to-9 mg group and one of 52 in the 3-to-6-to-9 mg group. Its adverse-event observation runs through 58 weeks.¹⁶²²

04 Was fatigue a major issue?

The phase 2 abstract reports fatigue in 0% to 46% across active groups. The registry records 23 affected participants out of 54 in the fixed 9 mg group and 11 out of 24 in the 6-to-9 mg group. Rates varied substantially by group.^1620,1622

05 Did side effects make people leave the study?

The phase 2 participant-flow table lists adverse events as the reason for study noncompletion in six eloralintide participants and two placebo participants. That table describes leaving the study. A separate, verified breakdown of stopping study treatment is still needed from the full journal report.^1622,1620

06 Were there serious adverse events?

The phase 2 registry reports at least one serious event in three placebo participants and between one and three participants in each active group. No deaths were reported.¹⁶²²

07 Was hair loss reported?

The phase 2 registry lists alopecia in several active groups, including six of 54 participants in the fixed 9 mg group and five of 52 in the 3-to-6-to-9 mg group. It reports none in the placebo group.¹⁶²²

08 Were gallbladder problems reported?

The phase 2 registry lists one serious cholelithiasis event in the fixed 9 mg group, which had 54 participants. Cholelithiasis means gallstones.¹⁶²²

09 Did researchers notice changes in heart rate?

In the 100-person phase 1b study, mean pulse fell by 14.4 beats per minute at week 12 in the 12 mg group, compared with 3.4 with placebo. The paper reported no symptomatic bradycardia in that study. The phase 2 registry separately lists bradycardia events in some groups.^1619,1622

10 Were mood symptoms reported?

Four participants in the 100-person phase 1b study had mood-related events. Three participants in the 12 mg group stopped treatment after mood events, which resolved within two to four days.¹⁶¹⁹

11 What is known about kidney or liver impairment?

Dedicated phase 1 protocols are studying eloralintide in people with kidney impairment and liver impairment. Their cited records have no posted results. The available evidence therefore leaves impairment-specific exposure and prescribing rules unresolved.^1633,1634

12 Could it affect oral medicines?

One registered study evaluates eloralintide with acetaminophen, and another evaluates it with a combined oral contraceptive. Both cited records have no posted results. These protocols identify interaction questions that researchers are investigating.^1635,1636

Phase 3 and current trials

01 What are the five ENLIGHTEN studies testing?

The five cited phase 3 protocols cover weight management without type 2 diabetes, weight management with diabetes, obstructive sleep apnea, knee osteoarthritis pain and persistent obesity during weekly incretin treatment. All five global registry records were recruiting and had no posted results in the cited snapshots.^{1618,1624,1625,1626,1627}

02 Has it been shown to treat sleep apnea?

ENLIGHTEN-3 is studying adults with obstructive sleep apnea and obesity or overweight. Its estimated enrollment is 800, and the cited record has no posted outcome results.¹⁶²⁵

03 Can it reduce knee pain or inflammation?

ENLIGHTEN-4 is studying knee osteoarthritis pain and weight outcomes, with estimated enrollment of 900. No results were posted in the cited record.¹⁶²⁶

04 Could it help when weight loss on an incretin medicine has stalled?

ENLIGHTEN-6 is studying eloralintide in adults with persistent obesity who are already treated with a weekly incretin. Its estimated enrollment is 900. The cited record has no posted results.¹⁶²⁷

05 Is eloralintide being studied with tirzepatide?

Yes. A completed phase 2 trial registered 367 participants with type 2 diabetes and tested eloralintide and tirzepatide, alone or in combination. The cited registry record has no posted results.¹⁶¹⁴

06 What is the macupatide combination research?

Two phase 2 protocols are studying macupatide and eloralintide, alone or together, in people with or without type 2 diabetes. Their estimated enrollments are 200 and 400, respectively. Neither cited record posts results.^1628,1629

07 Have Japanese and Chinese participants been studied?

The global registry lists a completed Japanese phase 1 protocol with 128 participants and a completed Chinese phase 1 protocol with 30 participants. Neither cited record has posted results. The Japanese protocol also has an official jRCT entry.^{1630,1631,1632}

08 What happens during screening and study visits?

Each trial has its own eligibility rules, tests and visit schedule. The public registry summaries describe study design and outcomes; the official consent materials and study staff supply the procedures for a specific site.^{1618,1624,1625,1626,1627}

09 What costs or medicines does a trial cover?

The cited registry entries do not give one payment or medication-coverage policy for every site. Those terms need to come from the specific trial's consent materials or study staff.^{1618,1624,1625,1626,1627}