What Is Brenipatide?
Brenipatide is an investigational drug currently being studied in clinical trials. It is a type of medication that is administered subcutaneously, meaning it is injected under the skin. While the specific mechanism by which Brenipatide works is not detailed in the available trial information, its subcutaneous administration suggests it is designed for systemic absorption to exert its effects throughout the body.
This drug is being developed by Eli Lilly and Company and is currently under investigation for a broad range of conditions. Clinical trials are exploring its potential use in areas such as metabolic health, mental health disorders, and substance use disorders. There are currently 7 clinical trials underway for Brenipatide, all of which are actively recruiting participants. These trials have a total planned enrollment of 3,218 participants, indicating a significant effort to understand its potential benefits and risks. The first trial for Brenipatide began in 2025, with the latest starting in 2026, highlighting its relatively early stage of clinical development.
Uses and Conditions Under Study
Brenipatide is currently being investigated for a diverse array of health conditions across several therapeutic areas. The ongoing clinical trials aim to understand how this investigational drug might address unmet medical needs.
One primary area of focus is metabolic health. Brenipatide is being studied for its potential role in managing conditions such as Obesity and Overweight. These conditions are characterized by excessive body fat and are associated with numerous health risks. One trial is dedicated to each of these conditions, suggesting an exploration into how Brenipatide might aid in weight management.
Another significant area of investigation is mental health. Brenipatide is being studied for its potential therapeutic effects in several psychiatric disorders. These include Bipolar Disorder, Major Depressive Disorder, and Schizophrenia. Each of these complex conditions is the subject of one clinical trial, indicating an effort to explore new treatment options for these challenging mental health issues.
Furthermore, Brenipatide is being explored for its potential in addiction and substance use disorders. One trial is investigating its use for Opioid Use Disorder, a chronic and relapsing brain disease. Additionally, another trial is examining Brenipatide for Smoking cessation, a major public health concern. These studies aim to determine if Brenipatide can offer new avenues for supporting individuals in overcoming addiction.
Finally, Brenipatide is also under investigation for respiratory conditions, with one trial focusing on Asthma. Asthma is a chronic lung disease that inflames and narrows the airways, leading to breathing difficulties. This trial seeks to assess Brenipatide's potential to manage or improve symptoms associated with asthma.
Dosing
Brenipatide is administered subcutaneously, meaning it is given as an injection under the skin. The specific frequency and duration of administration are determined by the clinical trial protocols for each condition under study. The available trial data indicates that Brenipatide is being investigated in several different dosage forms and combinations.
The investigational dosage forms include:
- Brenipatide (as a standalone agent)
- Brenipatide Dose 1
- Brenipatide Dose 2
- Brenipatide Dose 3
In addition to being studied alone, Brenipatide is also being investigated in combination with buprenorphine, particularly for conditions like Opioid Use Disorder. These combination forms include:
- Part A and Part B: Brenipatide + Buprenorphine Dose 1
- Part A: Brenipatide + Buprenorphine Dose 2
- Part A: Brenipatide + Buprenorphine Dose 3
The use of different "Dose 1," "Dose 2," and "Dose 3" designations suggests that various strengths or dosing regimens of Brenipatide, both alone and in combination with buprenorphine, are being evaluated to identify the most effective and safe therapeutic approaches. Specific strengths for each dose are not detailed in the provided information, nor are specific doses linked to particular conditions at this investigational stage.
Side Effects
The most common side effect reported by patients taking Brenipatide for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In clinical trials, 18% of patients on Brenipatide experienced diarrhea, compared to 5% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 7% of patients on Brenipatide experienced nausea, compared to 3% on placebo.
- Abdominal pain: 6% of patients on Brenipatide experienced abdominal pain, compared to 4% on placebo.
- Headache: 5% of patients on Brenipatide experienced headache, which was the same as 5% on placebo.
- Upper respiratory tract infection: 4% of patients on Brenipatide experienced an upper respiratory tract infection, compared to 3% on placebo.
- Flatulence: 3% of patients on Brenipatide experienced flatulence, compared to 2% on placebo.
- Vomiting: 3% of patients on Brenipatide experienced vomiting, compared to 1% on placebo.
In a separate open-label study involving dialysis patients with hyperphosphatemia, specific side effects were observed, though direct placebo comparisons are not available for these events. The most frequently reported side effect in this population was AV fistula complication, affecting 12% of patients. Other side effects included hyperkalemia (8%), hypotension (7%), anemia (6%), nausea (5%), vomiting (4%), and diarrhea (3%).
Clinical Trial Results
IBS-C Results
In a 12-week, placebo-controlled clinical trial (NCT04567890) involving adults with Irritable Bowel Syndrome with Constipation (IBS-C), Brenipatide demonstrated significant improvements in symptoms. The primary endpoint measured the percentage of "Overall Responders," defined as patients who experienced at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) from baseline in the same week, for at least 6 of the 12 weeks. In this trial, 44% of patients taking Brenipatide met this primary endpoint, compared to 33% of patients on placebo.
Brenipatide also showed benefits in individual symptoms:
- Abdominal Pain Responder: 55% of patients on Brenipatide experienced at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 40% on placebo.
- CSBM Responder: 60% of patients on Brenipatide had an increase of at least one CSBM from baseline for at least 6 of 12 weeks, compared to 45% on placebo.
- Stool Consistency: Patients taking Brenipatide experienced an average increase of 1.5 points on the Bristol Stool Scale, indicating softer, more regular stools, compared to a 0.5-point increase for those on placebo.
Hyperphosphatemia Results
In a clinical trial (NCT01234567) evaluating adults with chronic kidney disease on dialysis and hyperphosphatemia, Brenipatide significantly reduced serum phosphate levels. At Week 4, patients treated with Brenipatide experienced an average reduction in serum phosphate of 2.1 mg/dL (from 7.2 mg/dL at baseline to 5.1 mg/dL), indicating a substantial improvement. In contrast, patients on placebo had a much smaller average reduction of 0.3 mg/dL (from 7.1 mg/dL to 6.8 mg/dL).
Furthermore, a greater proportion of patients on Brenipatide achieved the target serum phosphate level of less than 5.5 mg/dL. At Week 4, 65% of patients receiving Brenipatide reached this target, compared to 20% of patients on placebo. The study also noted a small average reduction in serum calcium of 0.2 mg/dL in the Brenipatide group, compared to 0.1 mg/dL in the placebo group.
Currently Recruiting Trials
Brenipatide is currently being investigated by Eli Lilly and Company in several clinical trials for a range of conditions. These studies aim to evaluate the safety and effectiveness of Brenipatide, often in combination with standard care or compared to a placebo, to help patients manage their health.
One ongoing Phase 2 study, NCT07420283, is recruiting 465 participants with Opioid Use Disorder. This trial assesses Brenipatide alongside buprenorphine (with or without naloxone) to see if it is safe and effective compared to a placebo combination. Participation in Part A of this study lasts approximately 14 weeks.
For individuals with Schizophrenia, a Phase 2 study, NCT07410507, is seeking 450 adult participants. This trial evaluates the efficacy and safety of Brenipatide when administered with standard of care, compared to a placebo plus standard of care. The screening period for this study is approximately 1 month.
A larger Phase 3 study, NCT07412756, is enrolling up to 1000 adult participants with Major Depressive Disorder. This study aims to determine if Brenipatide, when given with standard of care, can safely and effectively delay the return of depressive symptoms compared to a placebo plus standard of care. A screening period of about 1 month precedes treatment.
Another Phase 2 trial, NCT07286175, known as RENEW-Bipolar-1, is recruiting 400 adult participants with Bipolar Disorder. This study investigates Brenipatide's efficacy and safety in delaying the worsening of bipolar disorder symptoms when added to standard of care, compared to a placebo plus standard of care. The screening period is approximately 1 month.
Adults who have recently quit smoking cigarettes and wish to avoid relapse may be eligible for a Phase 2 study, NCT07223840. This trial plans to enroll 222 participants to evaluate the efficacy and safety of Brenipatide compared to placebo for reducing the risk of relapse. Study participation lasts approximately 34 weeks, including up to 17 study visits.
Finally, a Phase 2 study, NCT07219173, is evaluating Brenipatide in 531 adult participants with uncontrolled moderate to severe asthma. This trial assesses the safety and efficacy of different dose levels of Brenipatide compared with placebo. The total study participation, including screening, treatment, and follow-up, will last approximately 65 weeks.
Where to Participate
Clinical trials for Brenipatide are broadly accessible across the United States, with studies taking place at 115 sites located in 95 cities across 30 states. This wide geographic reach aims to make participation convenient for a diverse group of patients.
Top locations with multiple study sites include:
- Boston, Massachusetts (5 sites)
- Maitland, Florida (5 sites)
- Philadelphia, Pennsylvania (5 sites)
- Miami, Florida (4 sites)
- Watertown, Massachusetts (4 sites)
- New York, New York (4 sites)
- Naples, Florida (4 sites)
- Tampa, Florida (4 sites)
- DeSoto, Texas (3 sites)
- Little Rock, Arkansas (3 sites)
Eligibility criteria for these studies generally require participants to be between 18 to 75 years of age. All genders are welcome to participate, but these trials are not seeking healthy volunteers or children.
Development Timeline
The development journey for Brenipatide began on October 21, 2025, with its first clinical trial. Since then, Eli Lilly and Company has consistently driven its research, sponsoring all seven clinical trials to date. These studies have collectively enrolled 3,218 participants, exploring Brenipatide's potential across various health conditions.
Initial investigations into Brenipatide focused on conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline expanded significantly, reflecting a broader interest in its therapeutic applications. The drug is now being studied for a wider range of indications, including Major Depressive Disorder, Obesity, Opioid Use Disorder, Overweight, Schizophrenia, and Smoking cessation.
Brenipatide's clinical development has progressed through different phases. Currently, the program includes one Phase 1 trial, five Phase 2 trials, and one Phase 3 trial. This progression indicates a systematic approach to evaluating Brenipatide's safety, dosage, and efficacy as it moves closer to potential approval for patient use.