Lilly's Eloralintide Obesity Drug Advances to Phase 3 Trials
Eli Lilly is preparing to commence late-stage clinical trials for its investigational amylin obesity drug next month, following encouraging results from a phase 2 study.
Lilly announced its plans to begin these late-stage trials of eloralintide, its experimental amylin obesity drug, next month. This decision follows the positive outcomes observed in a phase 2 study.
The study involved 263 overweight adult participants without type 2 diabetes, each exhibiting at least one obesity-related comorbidity.
In this mid-stage research, participants were randomly assigned to receive weekly subcutaneous injections of either a placebo or eloralintide. Dosages included 1, 3, 6, or 9 mg, or dose escalations from 6-9 mg or 3-9 mg, administered over 48 weeks.
Patients receiving the highest dose of Lilly's investigational drug experienced an average body weight reduction of 20.1% after 48 weeks. Conversely, the lowest eloralintide dose resulted in a 9.5% weight loss, compared to the 0.4% observed in the placebo group. Health tracking apps like Shotlee can help monitor weight changes throughout the study.
Participants initiating treatment at 6 mg and escalating to 9 mg via a two-step process saw a 19.9% weight reduction at 48 weeks. Those starting at 3 mg and using a three-step escalation experienced a 16.4% weight loss.
The most frequently reported side effects were mild to moderate gastrointestinal symptoms and fatigue. These occurred more commonly in patients receiving higher drug doses.
However, patients in groups receiving gradually increased doses of the selective amylin receptor agonist experienced fewer side effects. These were comparable to those reported by patients taking the lowest two doses, according to the company.
These promising research results support Lilly's efforts to strengthen its position in the expanding weight loss market and introduce next-generation therapies.
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While earlier obesity drugs primarily targeted the gut hormone GLP-1, drug manufacturers are now creating next-generation therapies. These therapies target other hormones or are designed to preserve muscle mass during fat loss.
Eloralintide is also under evaluation in a phase 1 trial both as a standalone treatment and in conjunction with tirzepatide (Zepbound), Lilly's dual GIP/GLP-1 receptor agonist.
Additionally, a phase 2 study is underway to assess the effects of eloralintide, both independently and combined with macupatide, Lilly's long-acting GIP receptor agonist drug candidate, in overweight or obese adults with type 2 diabetes.
Several other prominent drugmakers, including AbbVie and Roche, have also invested significantly in experimental amylin treatments.
Earlier this year, AbbVie invested $350 million to acquire rights to Gubra's long-acting amylin analog (GUB014295), currently in phase 1 development.
Zealand Pharma, in collaboration with Roche, is testing petrelintide, an experimental obesity drug, in a phase 2 study.
Novo Nordisk, Lilly's primary competitor in the obesity sector, announced earlier in the year that they are progressing both injectable and oral forms of amycretin, its dual GLP-1/amylin receptor agonist, into phase 3 trials for overweight or obese patients.
Novo and Pfizer are also engaged in a competitive bidding process for Metsera, a New York-based clinical-stage biotech company. Metsera's pipeline includes a once-monthly injectable amylin drug designed to treat obesity and other metabolic disorders.
