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Eloralintide and tirzepatide, type 2 diabetes (NCT06603571)

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Trial record

Trial name
Phase II, 48-week eloralintide and tirzepatide study in type 2 diabetes
Registry identifier
NCT06603571
Phase
Phase II
Sponsor
Eli Lilly and Company
Population
Adults with obesity or overweight and type 2 diabetes
Intervention
Eloralintide (LY3841136) and tirzepatide, alone or in combination
Comparator
Placebo and tirzepatide alone (parallel-group, double-blind, placebo-controlled)
Enrollment
367
Study status
Completed (confirmed 2026-10-01 via ClinicalTrials.gov; primary completion 2026-07-01, completion 2026-09-14)
Start date
2024-09-20
Completion date
2026-09-14
Results availability
No results posted on ClinicalTrials.gov as of 2026-10-01; sponsor topline announced 2026-09-30 (not peer reviewed)

Primary endpoints

  • Primary: percent change in body weight from baseline at week 48. Secondary: change in body weight; share of participants reaching at least 5% and at least 10% weight reduction; change in HbA1c (all at week 48); eloralintide pharmacokinetics (AUC and Cmax) (ClinicalTrials.gov, confirmed 2026-10-01)
  • Sponsor topline, announced 2026-09-30 (Lilly press release, not peer reviewed, no confidence intervals or p-values given, efficacy estimand): mean weight change -23.3% for the highest eloralintide plus tirzepatide combination, -14.8% for tirzepatide 15 mg alone, -3.0% for placebo; eloralintide alone -8.2% to -12.3% across its three dose levels. HbA1c change -2.9, -2.4 and -0.3 percentage points for those three groups respectively.

Primary registry record

A trial registration shows that a study exists. It does not show that the compound works, is safe, or has been approved, and recruitment says nothing about the eventual result.

This study compares eloralintide and tirzepatide, given alone or together, with placebo in adults who have obesity or overweight and type 2 diabetes. Participants were managed with diet and exercise alone or a stable dose of metformin, with or without an SGLT2 inhibitor, and had an HbA1c between 7.0% and 10.5%. Participation lasted about 64 weeks. The study ran under Lilly’s chronic weight management master protocol (NCT06143956), in the United States and Argentina.

On 30 September 2026 Lilly announced topline results. It reported mean weight change at 48 weeks of -23.3% for the highest eloralintide plus tirzepatide combination, against -14.8% for tirzepatide 15 mg alone and -3.0% for placebo, and -8.2% to -12.3% for eloralintide alone across its three dose levels. HbA1c fell by 2.9 percentage points for the highest combination, 2.4 for tirzepatide alone and 0.3 for placebo. Lilly said the most common adverse events were gastrointestinal, generally mild or moderate, mostly during dose escalation, and seen more often in the combination groups than with either drug alone. Discontinuation due to adverse events was 10.8% to 27.0% with the combination, 0% to 10.8% with eloralintide alone, 2.9% with tirzepatide and 16.7% with placebo. Lilly said it plans to start Phase 3 by the fourth quarter of 2026.

Read with care: these are a sponsor’s topline numbers from a press release, not a peer-reviewed paper, and no confidence intervals or p-values were given. Everyone in the study has type 2 diabetes, so the weight figures should not be set beside the Phase II study in adults without diabetes (NCT06230523). The registry lists exclusions for a resting pulse below 60 or above 100 bpm, a history of sinus bradycardia and recent symptomatic gallbladder disease, so participants were selected. A registry record describes a study’s plan and status. It is not a result, and it does not show that the drug works or is safe.

Study context

What the study tests

This Phase 2 study compares eloralintide (listed as LY3841136) and tirzepatide, alone or together, with placebo, double-blind, in adults with obesity or overweight and type 2 diabetes. It runs under the chronic weight management master protocol (NCT06143956). The primary endpoint is percent change in body weight from baseline to week 48. The record lists 367 participants and about 64 weeks of participation.

Who can take part

Adults aged 18 to 75 need type 2 diabetes with an HbA1c from 7.0% to 10.5%, treated for at least three months with diet and exercise alone or with a stable dose of metformin, with or without an SGLT2 inhibitor. They also need a BMI of at least 27 and a stable body weight. Exclusions include an eGFR below 45, a history of pancreatitis and a history of bradyarrhythmia or sinus bradycardia. Sites are in the United States and Argentina.

What the registry does not say

The study is marked completed, with primary completion on 1 July 2026, but no results are posted. HbA1c, the share of participants losing 5% or 10% of body weight and drug levels are secondary measures, so they are registered plans, not findings.

Source: ClinicalTrials.gov record NCT06603571, read on 2026-10-15. Registered plans can change.

References

  1. US National Library of Medicine. ClinicalTrials.gov registry records for the eloralintide clinical program. ClinicalTrials.gov. P1
  2. Eli Lilly and Company. Lilly's 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. Eli Lilly and Company, investor relations. 2026. NCT06603571 P1