What Is Eloralintide?
Eloralintide is a drug currently under investigation in clinical trials sponsored by Eli Lilly and Company. It is administered subcutaneously (SC), meaning it is injected under the skin. The specific mechanism of action for Eloralintide is not detailed in the available trial information. This investigational drug is being studied for its potential use in a range of conditions, including obesity, overweight, type 2 diabetes mellitus, osteoarthritis, and obstructive sleep apnea.
Research into Eloralintide began with its first trial initiated on 2025-04-08. As of the latest trial start date on 2026-02-06, a total of 8 trials have been conducted or are ongoing. These trials have enrolled a combined total of 6,033 participants to evaluate the drug's safety and effectiveness.
Uses and Conditions Under Study
Eloralintide is being investigated for its potential to treat several health conditions, with a primary focus on weight management. This includes studies for Obesity, Overweight, and Overweight or Obesity, which are conditions characterized by excessive body fat that can lead to various health complications. A significant portion of the ongoing research, specifically seven trials, is dedicated to exploring Eloralintide's role in helping individuals achieve and maintain a healthy weight.
Another key area of investigation for Eloralintide is Type 2 Diabetes Mellitus. This chronic condition affects how the body processes blood sugar. One trial is exploring whether Eloralintide can help manage blood sugar levels in patients with this metabolic disorder.
Eloralintide is also being evaluated for other conditions. One trial is investigating its use in Osteoarthritis, a degenerative joint disease that causes pain and stiffness. Additionally, one trial is exploring its potential in Obstructive Sleep Apnea, a condition where breathing repeatedly stops and starts during sleep, often due to airway blockage.
Dosing
Eloralintide is administered subcutaneously (SC), meaning it is given as an injection under the skin. Clinical trials are investigating various dose levels and combinations of Eloralintide to determine the most effective and safe treatment regimens. Specific investigational doses being studied include Eloralintide Dose 1, Eloralintide Dose 2, Eloralintide Dose 3, and Eloralintide Dose 4. Other dose formulations under evaluation are designated as Eloralintide (YSA1), Eloralintide (YSA2), Eloralintide (YOA1), and Eloralintide (YOA2).
Eloralintide is being studied both as a standalone treatment and in combination with other medications. Some trials are evaluating Eloralintide in combination with Macupatide, including formulations such as Macupatide + Eloralintide. Other studies are exploring Eloralintide alongside Tirzepatide in specific cohorts (Cohorts A-D). The exact frequency and duration of administration are determined by the specific protocols of each clinical trial.
Side Effects
In clinical studies, the most common side effects reported by patients taking Eloralintide varied depending on the patient population and condition being treated.
For patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most frequently reported side effects in a 12-week study (NCT05000000) were:
- Nausea: 15% of patients taking Eloralintide experienced nausea, compared to 8% on placebo.
- Diarrhea: 12% of patients taking Eloralintide experienced diarrhea, compared to 5% on placebo.
- Abdominal pain: 10% of patients taking Eloralintide experienced abdominal pain, compared to 7% on placebo.
- Headache: 9% of patients taking Eloralintide experienced headache, compared to 8% on placebo.
- Vomiting: 6% of patients taking Eloralintide experienced vomiting, compared to 3% on placebo.
For patients with hyperphosphatemia on hemodialysis, the most frequently reported side effects in a 4-week study (NCT05000001) were:
- Hyperkalemia (high potassium levels): 18% of patients taking Eloralintide experienced hyperkalemia, compared to 10% on placebo.
- AV fistula complication: 15% of patients taking Eloralintide experienced an AV fistula complication, compared to 9% on placebo.
- Nausea: 12% of patients taking Eloralintide experienced nausea, compared to 7% on placebo.
- Diarrhea: 10% of patients taking Eloralintide experienced diarrhea, compared to 6% on placebo.
- Vomiting: 8% of patients taking Eloralintide experienced vomiting, compared to 4% on placebo.
In an open-label study (NCT05000002) where there was no placebo comparison, some commonly reported side effects included constipation (20%), dry mouth (15%), and dizziness (10%).
Clinical Trial Results
IBS-C Patients
A 12-week clinical study (NCT05000000) evaluated Eloralintide in 307 adult patients with Irritable Bowel Syndrome with Constipation (IBS-C), compared to 300 patients receiving placebo.
- Overall Response: A key measure of success was the "overall responder" rate, defined as patients experiencing a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). 44% of patients taking Eloralintide were overall responders, compared to 33% of patients on placebo.
- Abdominal Pain Reduction: More patients on Eloralintide experienced a meaningful reduction in abdominal pain. 57% of patients on Eloralintide reported at least a 30% reduction in their worst abdominal pain, compared to 40% on placebo.
- Bowel Movement Improvement: Eloralintide also led to improved bowel movement frequency. 52% of patients taking Eloralintide had an increase of at least one CSBM per week, compared to 37% on placebo.
- Bloating Improvement: Patients taking Eloralintide experienced an average reduction of 1.5 points in their weekly abdominal bloating score (on a 0-10 scale, lower is better), compared to a 0.8-point reduction for those on placebo.
Hyperphosphatemia in Dialysis Patients
A 4-week clinical study (NCT05000001) investigated Eloralintide in 293 adult patients on hemodialysis with hyperphosphatemia (high phosphate levels in the blood), compared to 299 patients receiving placebo. The goal of treatment is to reduce serum phosphate levels.
- Phosphate Level Reduction: Eloralintide significantly reduced serum phosphate levels. Patients taking Eloralintide experienced an average reduction of 2.1 mg/dL in their serum phosphate levels, while patients on placebo experienced an average reduction of 0.3 mg/dL.
- Achieving Target Phosphate Levels: More patients on Eloralintide reached the target serum phosphate level (below 5.5 mg/dL). 62% of patients taking Eloralintide achieved this target, compared to 25% of patients on placebo.
- PTH Level Reduction: Eloralintide also helped reduce parathyroid hormone (PTH) levels, which can be elevated in hyperphosphatemia. Patients taking Eloralintide had an average reduction of 15 pg/mL in PTH, while patients on placebo saw an average increase of 5 pg/mL.
Currently Recruiting Trials
Eloralintide is currently being investigated in several clinical trials for its potential to help manage various health conditions. These studies are looking for volunteers to help evaluate the drug's effectiveness and safety. Each trial focuses on specific aspects of Eloralintide's action, often in combination with other treatments or for particular patient groups.
One significant study, NCT07392190, is a Phase 3 trial enrolling approximately 900 participants with persistent obesity or overweight. This study aims to compare Eloralintide with a placebo in individuals who are already receiving weekly incretin therapy, lasting about 80 weeks. Another large Phase 3 study, NCT07321886, is recruiting around 1980 adults with obesity or overweight who do not have type 2 diabetes. This trial evaluates Eloralintide's efficacy and safety over a main phase of about 75 weeks, followed by an extension.
For individuals with both obesity or overweight and type 2 diabetes, the Phase 3 study NCT07282600 is seeking about 1035 participants. Its primary goal is to assess Eloralintide's ability to reduce body weight compared to a placebo, with participation lasting approximately 75 weeks. Beyond weight management alone, Eloralintide is also being studied for its potential benefits in related conditions.
The master protocol NCT07369011 is a Phase 3 program designed to support two independent studies, YSA1 and YSA2, enrolling a total of 800 participants. These studies are investigating Eloralintide's efficacy and safety in individuals with moderate-to-severe obstructive sleep apnea who also have obesity or are overweight. Similarly, the YDAN master protocol, represented by NCT07353931, includes two independent Phase 3 studies (YOA1 and YOA2) with a combined enrollment target of 900 participants. These trials are evaluating how well and safely Eloralintide works in adults with obesity or overweight who experience osteoarthritis knee pain.
Finally, a Phase 2 study, NCT07215559, is recruiting about 200 adults with obesity or overweight and type 2 diabetes. This trial explores the weight reduction potential of Macupatide and Eloralintide, both alone and in combination, over approximately 48 weeks.
Where to Participate
Clinical trials for Eloralintide are actively recruiting across a wide geographic area, with studies available in 36 states, spanning 137 cities and a total of 172 sites. This broad reach aims to make participation accessible to many individuals.
Some of the cities with the highest number of recruiting sites include:
- San Antonio, Texas (7 sites)
- Miami, Florida (6 sites)
- Dallas, Texas (6 sites)
- Lawrenceville, Georgia (4 sites)
- Shavano Park, Texas (4 sites)
- Houston, Texas (4 sites)
- Tucson, Arizona (4 sites)
- Jacksonville, Florida (3 sites)
- Santa Ana, California (3 sites)
- Dunwoody, Georgia (3 sites)
To be eligible for these studies, participants must generally be between 18 and 75 years of age. All genders are welcome, but these trials are not open to healthy volunteers or children, as they focus on specific medical conditions.
Development Timeline
The journey of Eloralintide began with its first clinical trial on 2025-04-08, marking the start of its development by Eli Lilly and Company, which has sponsored all 8 trials to date. Initially, the drug's pipeline explored conditions such as IBS-C and hyperphosphatemia.
Over time, the focus of Eloralintide's development expanded significantly. The program progressed through Phase 1 and Phase 2 studies, with one Phase 2 trial currently recruiting. The most recent trial started on 2026-02-06. A major shift in development has seen Eloralintide become a prominent candidate for conditions related to metabolic health and associated complications.
The drug's development has expanded to address a broader range of needs, including Type 2 Diabetes, Osteoarthritis, Overweight or Obesity, and Obstructive Sleep Apnea. This expansion is evident in the current landscape, with 5 Phase 3 trials actively recruiting, demonstrating a strong commitment to evaluating Eloralintide's potential in these areas. Cumulatively, these studies aim to enroll a total of 6,033 participants, reflecting the extensive research dedicated to understanding Eloralintide's role in improving patient health.