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In a phase IIb trial involving adults with type 2 diabetes and overweight or obesity, the highest tested dose of eloralintide plus tirzepatide was associated with an average 23.3% body-weight loss over 48 weeks, compared with 14.8% on tirzepatide alone. The combination group also had more treatment discontinuations due to adverse events. Eli Lilly plans to move the combination into phase III development by year-end.
Adults with type 2 diabetes and overweight or obesity lost an average of 23.3% of their body weight over 48 weeks on the highest tested dose of investigational eloralintide plus tirzepatide in a phase IIb trial, compared with 14.8% among participants taking tirzepatide alone. The results, presented at the European Association for the Study of Diabetes annual meeting in Milan, suggest the combination may improve weight loss, but also showed more discontinuations linked to adverse events.
The 10-arm, double-blind trial randomized 367 adults in the United States and Argentina. Participants were assigned to placebo, eloralintide at one of three doses, tirzepatide alone, one of four combination-dose groups, or a group that began tirzepatide and added eloralintide at week 24. The headline weight-loss figures use the study’s efficacy estimand, a specified method for analyzing outcomes; the report does not provide the full statistical details or confidence intervals.
In the highest-dose combination group, 25% of participants lost at least 30% of their body weight, compared with 12% on tirzepatide alone. The report also said 96% in both the highest-dose combination and tirzepatide-alone groups reached an HbA1c below 7%, a commonly used blood-sugar target. HbA1c is a measure of average blood glucose over time. A smaller difference was reported for HbA1c below 5.7%: 77% in the highest-dose combination group versus 66% with tirzepatide alone.
The weight and blood-sugar results came with a tolerability trade-off. Treatment-emergent adverse events were reported by 84% of participants on the highest-dose combination, compared with 71.4% on tirzepatide alone. Discontinuation because of adverse events was reported in 27% versus 2.9%, respectively. One participant died in the lowest-dose combination group; investigators deemed the death unrelated to the study drug, according to the report.
Greater Weight Loss, More Dropouts
The findings matter because people with type 2 diabetes have historically lost less weight on GLP-1-based medicines than people without diabetes, according to the report. The 23.3% average loss in the highest-dose combination group was greater than the 20.9% cited for tirzepatide in non-diabetic populations. That is a comparison across different study populations, however, not a direct head-to-head result from this trial.
The potential benefit must be weighed against the notably higher rate of stopping treatment because of adverse events. The study provides an early indication that combining pathways could improve weight outcomes while supporting glucose control, but it does not establish how the balance of benefit and tolerability will hold up in larger or longer trials. The results are phase IIb evidence, not proof that the combination is safe or effective for routine use.
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How the Two Medicines Differ
Eloralintide is a selective amylin receptor agonist, while tirzepatide acts on GIP and GLP-1 receptors. Eli Lilly, which is developing the medicines, said the combination is intended to activate three hormone pathways involved in appetite and blood-sugar regulation. The trial administered the drugs as two separate injections; presenter Liana Billings said work is underway on a single-injection formulation.
Billings, MD, MMSc, of Endeavor Health in Evanston, Illinois, presented the results at the EASD meeting. She said the weight-loss findings were greater than those seen in earlier studies of people with type 2 diabetes. Eloralintide is also being studied on its own in phase III obesity trials. The combination results described here come from a separate phase IIb study.
“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
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Safety and Durability Still Open
The report does not establish whether the weight loss would continue beyond 48 weeks, how long participants maintained the results, or whether the findings will be reproduced in phase III. The available summary also does not give confidence intervals, detailed results for every dose group, or enough information to compare specific types and severity of adverse events. The higher discontinuation rate in the highest-dose combination group is a central issue for further study.
The study tested a limited number of participants across 10 groups, and its results do not show whether the combination is suitable for particular patient subgroups. The single death reported occurred in a lower-dose combination group and was judged by investigators to be unrelated to treatment; the report does not provide further details. The drugs were given as separate injections in this trial, so the performance and tolerability of a future single-shot formulation are also not established.
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Phase III Plans Await Details
Eli Lilly plans to advance the eloralintide-tirzepatide combination into phase III development by the end of the year, according to the source report. Those larger studies will need to test whether the weight and blood-sugar results are sustained and to examine adverse events and treatment discontinuations in more detail.
The report does not specify phase III trial designs, enrollment targets, or a timetable for results. Until those studies are completed and regulators review the evidence, the combination remains investigational and is not an established treatment option.
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Key Questions
How much weight did participants lose on the combination?
Participants in the highest-dose eloralintide-plus-tirzepatide group lost an average of 23.3% of body weight over 48 weeks under the trial’s efficacy estimand. The reported figure for tirzepatide alone was 14.8%.
Did the combination improve blood-sugar results?
The report said 96% of participants in both the highest-dose combination group and the tirzepatide-alone group reached HbA1c below 7%. A larger share of the combination group reached below 5.7%: 77%, compared with 66% on tirzepatide alone.
What safety concern appeared in the trial?
Adverse events were reported by 84% of participants in the highest-dose combination group versus 71.4% on tirzepatide alone. Discontinuations due to adverse events were 27% and 2.9%, respectively, according to the report.
Is the combination available as a treatment?
No. Eloralintide plus tirzepatide remains investigational. Eli Lilly plans to move the combination into phase III development by the end of the year, but the source does not provide a regulatory timeline.
Were the two medicines given in one injection?
No. Participants received two separate injections during the trial. Billings said a single-injection formulation is being developed, but its performance was not tested in the study described.
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