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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 23.3% weight loss over 48 weeks, compared with 14.8% with tirzepatide alone. Adverse events were more common with the combination, and 27% stopped treatment because of them versus 2.9% in the tirzepatide-only group. Eli Lilly plans to advance the combination to phase III by the end of the year.
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% among participants taking tirzepatide alone. The findings, presented at the European Association for the Study of Diabetes annual meeting in Milan, also showed more treatment discontinuations due to adverse events with the combination.
The weight-loss figures came from the trial’s efficacy estimand, a method for estimating treatment effect under specified assumptions. The highest-dose combination group also had a larger share of participants reaching substantial weight-loss thresholds: 25% lost at least 30% of their body weight, compared with 12% in the tirzepatide-only group. The report did not give the group sizes for those specific comparisons.
Blood-sugar measures were strong in both groups. At the highest combination dose, 96% reached an HbA1c below 7%, the standard target cited by presenter Liana Billings, MD, MMSc, of Endeavor Health. The same proportion reached that level with tirzepatide alone. HbA1c below 5.7% was reported in 77% of the combination group and 66% of the tirzepatide group.
The results came with a tolerability trade-off. Treatment-emergent adverse events were reported by 84% of participants receiving the highest-dose combination, versus 71.4% with tirzepatide alone. Discontinuation because of adverse events was 27% in the combination group and 2.9% in the tirzepatide-only group. One participant in a lowest-dose combination group died; investigators judged the death unrelated to the study drug.
Weight Loss Comes With Tolerability Costs
The results suggest that adding an amylin-receptor drug to tirzepatide could produce greater weight loss for some adults with type 2 diabetes than tirzepatide alone. The reported 23.3% average reduction is notable in a population that has historically lost less weight on GLP-1-based medicines than people without diabetes, as Billings said during her presentation.
But the adverse-event discontinuation rate is a central part of the story, not a secondary detail. In this trial, more than one in four participants in the highest-dose combination group stopped treatment because of adverse events, compared with fewer than one in 30 on tirzepatide alone. Whether the added weight loss would outweigh side effects for patients will require further study, including clearer information on the types and severity of events and how outcomes vary across doses.
The findings could matter for future treatment choices because the drugs target different hormonal pathways linked to appetite, weight and blood sugar. However, these are mid-stage trial results; they do not establish that the combination is safe or effective for routine use, and the product remains investigational.
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Two Hormone Pathways in One Regimen
The double-blind, parallel-group study randomized 367 adults with overweight or obesity and type 2 diabetes in the United States and Argentina across 10 groups. These included placebo, three eloralintide-only doses, tirzepatide alone, four combination doses, and a group that began tirzepatide and added eloralintide at week 24. The combination was given as two separate injections in the trial.
Eloralintide is a selective amylin-receptor agonist; tirzepatide activates both GIP and GLP-1 receptors. Eli Lilly said the approach is intended to act on GIP, GLP-1 and amylin, hormones involved in responses to eating and the regulation of hunger and blood sugar. The company is also studying eloralintide alone in phase III obesity trials.
Billings described tirzepatide 15 mg as a highly effective current therapy for type 2 diabetes and weight management. She said the combination results point to the possibility of tailoring medicine and doses to patients’ weight and glucose needs, while stressing the trial findings rather than establishing a treatment recommendation.
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Longer-Term Benefits Remain Unproven
The results are from a phase IIb study, and the supplied report does not provide detailed results for every dose group, the full range of adverse events, or longer-term follow-up beyond 48 weeks. It is also unclear whether the weight-loss and blood-sugar outcomes will be reproduced in a larger phase III trial or how the benefit-risk balance will differ among patient groups.
The 23.3% figure is an efficacy-estimand result, so it should not be read as a guarantee of the weight loss an individual patient would experience. The report describes group-level outcomes, not a prediction for any one person. It also does not establish whether the combination’s effects persist after treatment ends.
Although Billings compared the share reaching at least 30% weight loss with a benchmark she said is comparable to metabolic surgery, the trial did not directly compare the drug combination with surgery. No direct surgery comparison or conclusion that the treatments are equivalent was reported.
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Phase III Plans Set for Year-End
Eli Lilly plans to move the eloralintide-tirzepatide combination into phase III development by the end of the year, according to the source report. Larger, later-stage studies will be needed to test whether the phase IIb weight-loss and glucose findings hold up and to characterize side effects and discontinuations more fully.
Billings also said the company was working toward putting both medicines into a single injection; the study used separate shots. The timing and availability of such a formulation were not specified. Until further trial results and regulatory decisions, the combination remains investigational and is not an approved treatment.
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Key Questions
How much weight did participants lose with the combination?
In the efficacy-estimand analysis, participants receiving the highest tested dose of eloralintide plus tirzepatide lost 23.3% of body weight over 48 weeks, on average. Participants taking tirzepatide alone lost 14.8%.
Did the combination improve blood-sugar measures?
HbA1c below 7% was reported in 96% of participants in both the highest-dose combination group and the tirzepatide-only group. HbA1c below 5.7% was reported in 77% and 66%, respectively.
What safety concern appeared in the trial?
Adverse events were reported by 84% of participants in the highest-dose combination group and 71.4% in the tirzepatide-only group. Discontinuations due to adverse events were 27% versus 2.9%. Further trials will need to clarify the types and severity of these events.
Is eloralintide plus tirzepatide available as a treatment?
No. The combination is investigational and has not been established as an approved treatment. Eli Lilly plans to advance it to phase III development by the end of the year.
Was the combination compared directly with metabolic surgery?
No. A presenter said that the 30% weight-loss threshold reached by some participants is comparable to a benchmark associated with metabolic surgery, but the trial did not directly compare the drug combination with surgery.
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