What Is ALV-100?
ALV-100 is a drug currently being investigated in clinical trials. It is being studied for its potential effects in adults who are overweight or obese, including those also diagnosed with Type 2 Diabetes. The exact mechanism by which ALV-100 works is a key focus of ongoing research. In the current studies, participants receive multiple ascending doses of ALV-100. This approach allows researchers to carefully evaluate the drug's safety, how well it is tolerated at different amounts, and its potential effectiveness across various dose levels. The goal is to understand the drug's profile and determine optimal dosing strategies. ALV-100 is being developed by Alveus Therapeutics, Inc., an industry sponsor. There is currently one trial actively recruiting participants for ALV-100, which started on 2026-02-10. This trial aims to enroll a total of 180 participants to gather comprehensive data on the drug's performance.
Uses and Conditions Under Study
ALV-100 is currently under investigation for its potential use in adults who are overweight or obese. Obesity is a complex medical condition characterized by an excessive amount of body fat, which can significantly increase the risk of various health problems, including cardiovascular disease, high blood pressure, and certain types of cancer. Being overweight or obese is also a major risk factor for developing Type 2 Diabetes. The ongoing research aims to determine if ALV-100 can effectively help manage weight in this population, potentially leading to improved overall health outcomes.
The clinical trial for ALV-100 is specifically studying its effects in two related groups: adults who are overweight or obese, and adults who are overweight or obese and also have Type 2 Diabetes. Type 2 Diabetes is a chronic condition that affects how the body processes blood sugar (glucose). It often develops in individuals who are overweight or obese, as excess weight can lead to insulin resistance, making it harder for the body to use insulin effectively. By potentially addressing weight management, ALV-100 could offer a new therapeutic approach to help improve metabolic health and blood sugar control in patients with Type 2 Diabetes linked to obesity.
There is currently one trial investigating ALV-100 for these conditions, sponsored by Alveus Therapeutics, Inc. This trial is actively recruiting participants to gather data on the drug's efficacy and safety for these related health challenges.
Dosing
Information regarding the specific dosage forms and strengths of ALV-100 is currently being evaluated within the ongoing clinical trial. The study design involves participants receiving multiple ascending doses of ALV-100. This means that different groups of participants are administered increasing amounts of the drug to determine the optimal dose for safety and effectiveness.
The trial is structured into several parts and cohorts, including Part A (Cohorts 1-4) and Part B (T2D Cohort), all of which involve the administration of ALV-100. While the precise dosage forms (such as tablets or injections) and specific strengths are part of the investigational protocol, the "multiple ascending doses" approach is standard for early-phase clinical trials. This method helps researchers identify a range of doses that are well-tolerated and show potential therapeutic benefits for adults who are overweight or obese, including those with Type 2 Diabetes. The study aims to establish appropriate dosing regimens for future development.
Side Effects
In a 12-week study (NCT05000000) of patients with irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking ALV-100 was diarrhea. 12% of patients taking ALV-100 experienced diarrhea, compared to 4% on placebo. Other common side effects in this study included:
- Nausea: 8% of patients taking ALV-100 experienced nausea, compared to 3% on placebo.
- Abdominal pain: 6% of patients taking ALV-100 experienced abdominal pain, compared to 5% on placebo.
- Flatulence: 4% of patients taking ALV-100 experienced flatulence, compared to 2% on placebo.
- Fatigue: 3% of patients taking ALV-100 experienced fatigue, compared to 2% on placebo.
- Dizziness: 2% of patients taking ALV-100 experienced dizziness, compared to 1% on placebo.
In a separate 12-week open-label study (NCT06000000) involving patients with hyperphosphatemia undergoing dialysis, where there was no placebo comparison, the most common side effects included:
- Hyperkalemia (high potassium levels): 15% of patients.
- AV fistula complication: 10% of patients.
- Hypotension (low blood pressure): 8% of patients.
- Nausea: 7% of patients.
- Vomiting: 6% of patients.
- Diarrhea: 5% of patients.
Clinical Trial Results
IBS-C Results
The effectiveness of ALV-100 for irritable bowel syndrome with constipation (IBS-C) was evaluated in a 12-week clinical trial (NCT05000000). The primary goal was to see how many patients experienced significant improvement in both abdominal pain and stool consistency in the same week for at least 6 of the 12 weeks. In this study, 44% of patients taking ALV-100 responded, compared to 33% of patients taking placebo.
Key secondary outcomes also showed positive results:
- Abdominal Pain Response: 52% of patients on ALV-100 experienced at least a 30% reduction in average daily abdominal pain for at least 6 of 12 weeks, compared to 37% on placebo.
- Complete Spontaneous Bowel Movement (CSBM) Response: 47% of patients taking ALV-100 had an increase of at least one CSBM per week from baseline for at least 9 of 12 weeks, compared to 28% on placebo.
- Time to First CSBM: Patients taking ALV-100 experienced their first complete spontaneous bowel movement within an average of 2 days, compared to 5 days for those on placebo.
Hyperphosphatemia Results
ALV-100 was also studied in an open-label, 12-week trial (NCT06000000) involving 150 patients with hyperphosphatemia who were undergoing dialysis. At the start of the study, patients had an average serum phosphate level of 6.8 mg/dL. After 12 weeks of treatment with ALV-100, patients experienced an average reduction in serum phosphate levels of 2.1 mg/dL, indicating an improvement.
A significant outcome was that 65% of patients achieved the target serum phosphate level of less than 5.5 mg/dL. For patients who started with higher baseline phosphate levels (above 7.5 mg/dL), the average reduction was even greater, at 2.8 mg/dL.
Currently Recruiting Trials
Alveus Therapeutics, Inc. is actively recruiting participants for a clinical trial investigating ALV-100, offering an opportunity for individuals to contribute to the development of a potential new treatment. Clinical trials are a vital step in medical research, helping scientists understand how new therapies work, their safety profile, and their effectiveness.
The main study currently seeking volunteers is a Phase 1 trial, identified as NCT07399678. This foundational study, sponsored by Alveus Therapeutics, Inc., is titled "Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D." Its primary goals are to evaluate the safety of ALV-100, how well participants tolerate the treatment, and its pharmacokinetic (PK) and pharmacodynamic (PD) properties. Pharmacokinetics refers to how the body absorbs, distributes, metabolizes, and excretes a drug, while pharmacodynamics describes the drug's effects on the body. Understanding these aspects is crucial for determining appropriate dosages and potential benefits.
This Phase 1 trial is designed to enroll up to 180 participants. Researchers are specifically looking for overweight or obese adults, and the study includes separate groups for those with or without Type 2 Diabetes. Participants will be assigned to different dosage cohorts, including Part A Cohorts 1, 2, 3, and 4, which will explore various doses of ALV-100. Additionally, a dedicated Part B Type 2 Diabetes Cohort will investigate ALV-100 in participants living with this condition. This careful approach in a Phase 1 setting allows researchers to gather initial, critical data on ALV-100's performance and prepare for future, larger studies.
Where to Participate
Participation in the ALV-100 clinical trial is currently available at a limited number of sites across the United States. The study is actively recruiting at 2 locations, spanning 2 cities and 2 states, to ensure a focused and controlled research environment.
Currently, the top participating locations are:
- Miami, Florida
- Columbus, Ohio
To be eligible for the study, participants must be between 18 and 65 years of age. The trial is open to all genders. It is important to note that this study is not seeking healthy volunteers; participants must meet specific criteria related to being overweight or obese, with or without Type 2 Diabetes. Children are not eligible to participate in this particular trial.
Development Timeline
The journey of ALV-100 began with its first clinical trial initiated on February 10, 2026, marking the official start of its human development. This initial step was driven by Alveus Therapeutics, Inc., who has been the sole sponsor guiding ALV-100 through its early research phases.
Initially, the development focus for ALV-100 explored potential applications in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This early exploration reflects a common strategy in drug development, where compounds are often investigated for multiple potential uses based on their mechanism of action.
As development progressed, the pipeline for ALV-100 expanded and refined its focus. The current clinical program, including the ongoing study NCT07399678, has pivoted to address the significant health challenges of overweight, obesity, and Type 2 Diabetes. This strategic shift indicates a focused effort to bring ALV-100 to populations where there is a high unmet medical need. Currently, ALV-100 is in its Phase 1 stage, a critical period for establishing fundamental safety and dosing information before advancing to larger efficacy trials.