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In a phase IIb trial of adults with obesity or overweight and type 2 diabetes, the highest tested dose of eloralintide plus tirzepatide was associated with 23.3% weight loss at 48 weeks, compared with 14.8% for tirzepatide alone. Adverse events and treatment discontinuations were more common with the combination; Eli Lilly plans to move it into phase III development by year-end.
An investigational combination of eloralintide and tirzepatide was associated with an average 23.3% body-weight loss over 48 weeks among adults with type 2 diabetes in a phase IIb trial, compared with 14.8% for tirzepatide alone. The results, presented at the European Association for the Study of Diabetes meeting in Milan, also showed more adverse-event-related treatment discontinuations with the combination, a trade-off that will need further study.
The double-blind trial randomized 367 adults with overweight or obesity and type 2 diabetes in the United States and Argentina across 10 groups. These included placebo, eloralintide alone at three dose levels, tirzepatide alone, four combination-dose groups, and a group that began tirzepatide before adding eloralintide at week 24. The reported 23.3% weight reduction was for the highest tested combination dose, using the study’s efficacy estimand; it is not a result for every participant or every dose.
At least 30% body-weight loss was reached by 25% of participants in the highest-dose combination group, compared with 12% receiving tirzepatide alone. The report also said 96% of participants in each of those two groups reached an HbA1c below 7%, a commonly used blood-sugar target. HbA1c below 5.7% was reported in 77% of the highest-dose combination group and 66% of the tirzepatide-only group.
Tolerability results were less favorable for the combination. Treatment-emergent adverse events occurred in 84% of the highest-dose group, compared with 71.4% on tirzepatide alone. Discontinuations attributed to adverse events were 27% and 2.9%, respectively. One participant in the lowest-dose combination group died; investigators judged the death unrelated to the study drug, according to the report.
Weight Loss Comes With a Tolerability Trade-Off
The findings suggest that targeting more than one hormone pathway may increase weight loss for some people with type 2 diabetes beyond the result seen with tirzepatide alone in this trial. That matters because weight management and blood-sugar control are often linked treatment goals, and the study reported strong HbA1c results in both groups.
But the higher rate of adverse events and, particularly, the larger share of participants stopping treatment in the highest-dose combination group complicate the apparent benefit. The results are from a relatively small, 48-week phase IIb study, not evidence that the combination is approved, suitable for routine use, or superior for long-term health outcomes. Larger trials will need to examine whether the additional weight loss can be maintained and how the benefits compare with side effects and discontinuation.
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How the Two Medicines Work Together
Eloralintide is an investigational selective amylin receptor agonist; tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for weight management, activates GIP and GLP-1 receptors. The combination is designed to act on three hormone pathways involved in appetite and blood-sugar regulation. Eli Lilly said these hormones are naturally released after eating and act through distinct receptors.
The report places the 23.3% result above the 20.9% weight loss cited for tirzepatide in people without diabetes. Those figures come from different trial populations, however, and should not be read as a direct head-to-head comparison. The trial combination was also given as two separate injections. Presenter Liana Billings, MD, MMSc, of Endeavor Health, said a single-injection formulation is being planned. Eloralintide is also being evaluated alone in phase III obesity trials.
“These substances are released naturally by the body after eating, with each acting through its own distinct receptor to help regulate hunger and blood sugar.”
— Eli Lilly, the developer, in a statement
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Questions Before Larger Trials
The phase IIb results do not establish long-term safety, durability of weight loss, or outcomes beyond 48 weeks. The supplied report does not provide detailed rates for individual adverse events, nor does it establish which patients might be most likely to benefit or stop treatment. It also remains unclear how the results will compare with other therapies in a direct, longer-term study.
The 23.3% figure applies to the highest tested dose under the efficacy estimand, and the study included several dose groups. The figures should not be generalized to all people with diabetes or interpreted as a guaranteed individual outcome. The trial was funded or conducted by the developer only as described in the source material; fuller information about study sponsorship and detailed methods would be needed to assess those aspects independently.
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Phase III Plans and Formulation
Eli Lilly plans to advance the combination into phase III development by the end of the year, according to the report. Larger studies should provide more information on the balance between weight and glucose outcomes, adverse events, and treatment discontinuation. The company is also working toward combining the medicines in a single injection; the phase IIb trial used two separate injections. Until further evidence and regulatory review, the combination remains investigational.
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Key Questions
How much weight did participants lose with the combination?
Participants receiving the highest tested dose lost 23.3% of body weight over 48 weeks under the trial’s efficacy estimand. The result does not describe every dose or guarantee the same outcome for an individual.
How did the combination compare with tirzepatide alone?
The trial reported 23.3% weight loss in the highest-dose combination group and 14.8% with tirzepatide alone over 48 weeks. Adverse-event-related discontinuations were also higher with the combination: 27% versus 2.9%.
Did the combination improve blood-sugar measures?
The report said 96% of participants in both the highest-dose combination and tirzepatide-only groups reached HbA1c below 7%. HbA1c below 5.7% was reported for 77% and 66%, respectively.
Is eloralintide plus tirzepatide available as a treatment?
No. The combination is investigational and was tested in a phase IIb study. Eli Lilly plans phase III development by year-end, but the supplied report does not describe an approval or launch.
Source: rss
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