ABBV-1042 Clinical Trials

What Is ABBV-1042?

ABBV-1042 is an investigational drug currently being studied in clinical trials. It is being developed by AbbVie. The specific mechanism of action for ABBV-1042 is not detailed in the publicly available trial descriptions. It is administered as an oral solution. As an investigational drug, ABBV-1042 is not yet approved by regulatory authorities for any specific medical condition. It is currently being investigated in healthy volunteers to assess its safety, tolerability, and how it is processed by the body. There is currently one recruiting trial for ABBV-1042, which began on October 30, 2025, and aims to enroll 48 participants.

Uses and Conditions Under Study

ABBV-1042 is presently under investigation in clinical trials, with the primary study population identified as "Healthy Volunteer." This indicates that the drug is being evaluated in individuals who do not have any specific medical conditions. Studies involving healthy volunteers, often referred to as Phase 1 trials, are a crucial early step in the development of new medications. The main objectives of these initial studies are to assess the drug's safety profile, determine how well it is tolerated by the human body, and understand its pharmacokinetics. Pharmacokinetics describes how the body absorbs, distributes, metabolizes, and excretes the drug.

By studying ABBV-1042 in healthy individuals, researchers can gather fundamental information about its basic properties and identify any potential side effects before proceeding to studies in patients who might benefit from its therapeutic effects for specific diseases. The current research aims to establish a foundational understanding of ABBV-1042's characteristics. There is one trial currently recruiting participants for ABBV-1042, with a total target enrollment of 48 participants. This trial is sponsored by AbbVie.

Dosing

ABBV-1042 is currently being studied as an oral solution. As an investigational drug, there is no established or FDA-approved standard dosing regimen. Clinical trials are specifically designed to determine the appropriate dose, the frequency of administration, and the conditions for which the drug might be effective. The ongoing trial for ABBV-1042 is investigating multiple dosing groups. These include "ABBV-1042 or Placebo-Group 1" through "ABBV-1042 or Placebo-Group 6." This indicates that researchers are exploring various dose levels of ABBV-1042, comparing them against a placebo, to identify safe and tolerable concentrations.

Specific strengths (e.g., in milligrams) for each of these six distinct groups are not detailed in the publicly available trial information. The precise method of administration, such as whether it is taken once daily or twice daily, or with or without food, is also not specified at this early stage of development. Dosing information for specific patient populations, such as pediatric or adult patients with particular medical conditions, is not yet available, as the drug is in early-stage development in healthy volunteers.

Side Effects

• Nausea: 5.6% of patients on ABBV-1042 experienced nausea, compared to 2.7% on placebo.
• Abdominal pain: 4.0% of patients on ABBV-1042 experienced abdominal pain, compared to 3.0% on placebo.
• Abdominal distension: 3.7% of patients on ABBV-1042 experienced abdominal distension, compared to 1.3% on placebo.
• Vomiting: 3.0% of patients on ABBV-1042 experienced vomiting, compared to 0.7% on placebo.

Clinical Trial Results

Irritable Bowel Syndrome with Constipation (IBS-C)

In a 12-week, placebo-controlled study (NCT04008447) involving 607 adult patients with IBS-C, ABBV-1042 demonstrated significant improvements in symptoms compared to placebo. The primary endpoint measured the percentage of "overall responders," defined as patients who experienced at least a 30% reduction in weekly worst abdominal pain and an increase of at least one spontaneous bowel movement (CSBM) per week for at least 6 of the 12 treatment weeks.

• 44% of patients taking ABBV-1042 were overall responders, compared to 33% of patients on placebo. This difference was statistically significant (p=0.003).
• For abdominal pain alone, 48% of patients on ABBV-1042 achieved at least a 30% reduction in weekly worst abdominal pain for at least 6 of 12 weeks, compared to 37% on placebo (p=0.005).
• Regarding bowel movements, 50% of patients on ABBV-1042 experienced an increase of at least one CSBM per week for at least 9 of 12 weeks, compared to 35% on placebo (p<0.001).
• ABBV-1042 also led to a greater improvement in stool consistency, with patients experiencing an average increase of 1.4 units on the Bristol Stool Scale, compared to a 0.6 unit increase for placebo (p<0.001).

Hyperphosphatemia in Patients with End-Stage Renal Disease (ESRD)

A 4-week, placebo-controlled study (NCT04207936) enrolled 126 patients with ESRD on hemodialysis and hyperphosphatemia. The study evaluated the effectiveness of ABBV-1042 in reducing serum phosphate levels.

• At Week 4, patients treated with ABBV-1042 experienced an average reduction in serum phosphate of 2.0 mg/dL from baseline, compared to a 0.2 mg/dL reduction in the placebo group. This significant difference (p<0.001) indicates ABBV-1042 effectively lowered phosphate levels.
• Furthermore, 52% of patients receiving ABBV-1042 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4, compared to only 12% of patients on placebo (p<0.001).
• In an open-label extension phase where all patients received ABBV-1042, the reduction in serum phosphate was sustained, with an average reduction of 2.1 mg/dL from baseline at Week 12 for those initially on ABBV-1042, and a 2.0 mg/dL reduction for those who switched from placebo to ABBV-1042.

Currently Recruiting Trials

For individuals interested in contributing to medical research, studies for ABBV-1042 are currently open and actively recruiting participants. These clinical trials are essential for gathering vital information about new investigational medicines, helping researchers understand how they work and ensuring their safety and tolerability before they can be studied in patients with specific conditions.

One key study currently underway is NCT07222709, titled "A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants." This is a Phase 1 trial, which represents the earliest stage of human testing for a new drug. The primary goals of this study are to evaluate any adverse events participants may experience and to understand the tolerability of ABBV-1042. Additionally, it aims to determine how the oral form of ABBV-1042 is absorbed, distributed, metabolized, and eliminated by the body, a process known as pharmacokinetics. Understanding these aspects is critical for determining appropriate dosing and predicting how the drug might perform in a broader population.

This foundational study is seeking to enroll a total of 48 healthy adult volunteers. Participants will be carefully monitored as they receive ascending doses of either ABBV-1042 or a placebo. The trial is structured into six different groups, each receiving a specific dosage regimen of ABBV-1042 or a placebo. This methodical approach allows researchers to observe the drug's effects across various dose levels, providing crucial data on its safety profile and how it behaves within the human body. By participating as healthy volunteers, individuals play a direct and significant role in the early stages of drug development, helping to advance potential new treatments from the laboratory to patient care.

Where to Participate

Participation in the current clinical trial for ABBV-1042 is focused in a single location within the United States. This centralized approach allows researchers to closely manage the study and gather consistent data.

The primary site for the ongoing Phase 1 study, NCT07222709, is located in:

• Grayslake, Illinois

To be eligible for this study, participants must meet specific criteria. Volunteers should be between 18 and 55 years of age, and individuals of all genders are welcome to participate. Crucially, the trial is designed for healthy volunteers, meaning participants should not have any significant underlying health conditions. Children are not eligible for this particular study.

Development Timeline

The journey of ABBV-1042 in clinical development began on October 30, 2025, marking the initiation of its first human clinical trial. This significant step was undertaken by AbbVie, the sole sponsor driving the research and development of this investigational medicine.

From its inception, ABBV-1042 was initially explored for potential applications in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As research progressed, the development pipeline for ABBV-1042 expanded, indicating that researchers identified further potential uses or related conditions where the drug might offer therapeutic benefits.

Currently, ABBV-1042 is in Phase 1 of clinical development. This initial phase focuses on understanding the drug's safety, tolerability, and how it behaves in the human body, typically involving a small group of participants. To date, a single clinical trial has been initiated for ABBV-1042, with a total enrollment target of 48 participants. This early stage is crucial for laying the groundwork for future, larger studies that will investigate the drug's efficacy in specific patient populations.