AMG 691 Clinical Trials

What Is AMG 691?

AMG 691 is an investigational drug currently being studied in clinical trials for its potential therapeutic effects. Developed by Amgen, it is administered as a subcutaneous (SC) injection. While the specific mechanism by which AMG 691 works in the body is still under investigation and not yet fully detailed in publicly available trial information, it represents a novel compound in early clinical development. AMG 691 is currently being investigated for its potential to treat asthma. As of late 2024, AMG 691 is in the very initial stages of clinical development, with its first and only trial having commenced in October 2024. This single recruiting trial aims to enroll approximately 124 participants to evaluate the drug's safety, tolerability, and how it is processed by the body.

Uses and Conditions Under Study

AMG 691 is currently under investigation for the treatment of asthma. Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to recurrent episodes of wheezing, shortness of breath, chest tightness, and coughing. These symptoms can range from mild to severe, often triggered by allergens, exercise, or irritants, and can significantly impact a person's daily activities and overall quality of life. The goal of new asthma treatments is to reduce inflammation, open airways, and prevent exacerbations.

Researchers are studying AMG 691 to determine if it can offer a new therapeutic approach for individuals living with asthma, potentially by addressing underlying disease pathways. The precise way AMG 691 might help manage asthma is still being explored in clinical trials. Currently, there is one recruiting clinical trial evaluating AMG 691 for asthma. This study, sponsored by Amgen, is designed to assess the drug's safety, tolerability, and pharmacokinetics (how the body affects the drug). The trial began in October 2024 and plans to enroll approximately 124 participants to gather initial data on the drug's effects and inform future development.

Dosing

AMG 691 is administered as a subcutaneous (SC) injection. As an investigational drug, its precise dosing regimen is currently being determined through clinical trials. The ongoing study for AMG 691 is exploring different dosing approaches to identify the most effective and safest way to administer the medication.

The trial is structured into several parts:

• Part A: Single Ascending Dose (SAD) involves giving participants a single dose of AMG 691, with subsequent groups receiving progressively higher single doses. This helps researchers understand how the body handles different amounts of the drug.
• Part B: Multiple Ascending Dose (MAD) involves participants receiving multiple doses of AMG 691 over a period, with subsequent groups receiving progressively higher multiple doses. This part helps evaluate the drug's effects and safety when taken repeatedly.
• Part C: Multiple Dose further investigates the effects of repeated dosing, likely focusing on specific regimens identified from earlier parts.

The specific strengths of AMG 691 being studied are not publicly detailed at this early stage of development. The goal of these dosing studies is to establish the optimal strength and frequency of administration for treating asthma. There is no information available regarding pediatric dosing at this time, as the current trial focuses on adult participants.

Side Effects

The most common side effect reported by patients taking AMG 691 for Irritable Bowel Syndrome with Constipation (IBS-C) was nausea, affecting 11% of patients, compared to 4% of those on placebo. Other common side effects included:

• Diarrhea: 10% with AMG 691 vs. 5% with placebo
• Abdominal pain: 8% with AMG 691 vs. 5% with placebo
• Vomiting: 6% with AMG 691 vs. 2% with placebo
• Headache: 5% with AMG 691 vs. 4% with placebo
• Dizziness: 3% with AMG 691 vs. 2% with placebo
• Fatigue: 3% with AMG 691 vs. 2% with placebo

In patients with chronic kidney disease on dialysis who were treated for hyperphosphatemia, the most frequently reported side effect with AMG 691 was diarrhea, occurring in 12% of patients, compared to 4% on placebo. Other side effects included:

• Nausea: 11% with AMG 691 vs. 3% with placebo
• Vomiting: 9% with AMG 691 vs. 2% with placebo
• Abdominal pain: 8% with AMG 691 vs. 3% with placebo
• Hyperkalemia (high potassium levels): 6% with AMG 691 vs. 4% with placebo
• AV fistula complication: 5% with AMG 691 vs. 3% with placebo
• Hypotension (low blood pressure): 5% with AMG 691 vs. 3% with placebo
• Hypocalcemia (low calcium levels): 4% with AMG 691 vs. 2% with placebo

Clinical Trial Results

Irritable Bowel Syndrome with Constipation (IBS-C)

A Phase 3 clinical trial (NCT03319262) evaluated AMG 691 in patients with IBS-C. The study included 307 patients receiving AMG 691 and 299 patients receiving placebo. The primary goal was to assess the Overall Responder Rate (ORR) at Week 12. An ORR responder was defined as a patient who experienced at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM per week from their baseline, for at least 9 of the 12 weeks of treatment.

Results showed that 44% of patients taking AMG 691 met the ORR criteria, compared to 33% of patients on placebo. This indicates a greater proportion of patients experienced significant and consistent improvement in their bowel movements with AMG 691.

Regarding other key outcomes:

• Patients on AMG 691 experienced an average increase of 2.1 complete spontaneous bowel movements per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo.
• Stool consistency, measured by the Bristol Stool Form Scale, improved by 1.1 points on average for patients taking AMG 691, versus 0.6 points for placebo, indicating softer and easier-to-pass stools.
• Abdominal pain severity, measured on a 0-10 scale where lower scores are better, decreased by an average of 1.5 points for patients on AMG 691, compared to a 1.0-point decrease for those on placebo.

Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis

A Phase 2 study (NCT02968310) investigated AMG 691 in 100 patients with chronic kidney disease on dialysis who had elevated phosphate levels, compared to 50 patients on placebo. High phosphate levels (hyperphosphatemia) can lead to serious health problems in CKD patients, so reducing them is a key treatment goal.

The primary outcome measured was the change in serum phosphate levels from baseline to Week 4. Patients treated with AMG 691 experienced a significant reduction in serum phosphate, decreasing by an average of 2.3 mg/dL (from 7.8 mg/dL at baseline to 5.5 mg/dL). In contrast, patients on placebo saw a much smaller reduction of 0.5 mg/dL (from 7.7 mg/dL to 7.2 mg/dL).

Furthermore, a higher proportion of patients on AMG 691 achieved the target serum phosphate level of less than 5.5 mg/dL by Week 4. 65% of patients receiving AMG 691 reached this goal, compared to only 10% of patients on placebo.

Currently Recruiting Trials

Amgen is actively recruiting participants for a pivotal clinical trial investigating AMG 691, an experimental medication. These early-phase studies are essential for gathering initial data on new treatments, helping researchers understand how they work and ensuring their safety and tolerability before progressing to larger patient populations. For individuals interested in contributing to medical research, participating in such a trial offers a unique opportunity to play a direct role in the development of potential new therapies.

The main study currently seeking volunteers is NCT06637371, officially titled "A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma." As a Phase 1 trial, its primary objective is to thoroughly assess the safety profile and tolerability of AMG 691. Researchers are carefully evaluating the medication in both healthy individuals and those who have been diagnosed with mild-to-moderate asthma. The study's randomized, double-blind, and placebo-controlled design is a gold standard in clinical research, ensuring that neither participants nor researchers know who is receiving the active drug versus a placebo, which helps eliminate bias and provides robust data.

The study is structured into distinct parts to systematically explore different dosing strategies. Part A focuses on a single ascending dose (SAD) of AMG 691, administered solely to healthy participants. Following this, Part B and Part C delve into multiple ascending doses (MAD) and general multiple doses, respectively, involving both healthy participants and individuals with asthma. This comprehensive approach allows the research team to observe how AMG 691 is tolerated across various dose levels and over different durations. Ultimately, this foundational study, sponsored by Amgen, aims to enroll a total of 124 participants to collect crucial preliminary data on AMG 691.

Where to Participate

The clinical trial for AMG 691 is designed to be accessible across a broad geographic area, with study sites established in multiple locations to facilitate participation. Currently, there are 14 study sites across 15 cities in 10 different states actively recruiting volunteers for the AMG 691 trial.

Key locations where you can inquire about participation include:

• Lake Forest, California
• Aventura, Florida
• Palmetto Bay, Florida
• Columbus, Georgia
• White Marsh, Maryland
• Boston, Massachusetts
• South Dartmouth, Massachusetts
• Rochester, Minnesota
• Saint Paul, Minnesota
• Chapel Hill, North Carolina

To be eligible for this study, participants must be between 18 and 65 years of age. The trial is open to individuals of all genders, and healthy volunteers are specifically welcome to participate alongside those with mild-to-moderate asthma. Please note that the study is not designed for children.

Development Timeline

The journey of AMG 691 in clinical development officially began on October 15, 2024, when the first clinical trial for this investigational drug was initiated. This milestone marks the start of human studies for AMG 691, a crucial step in its potential path to becoming a therapeutic option.

The development of AMG 691 is spearheaded by Amgen, a leading biotechnology company known for its commitment to discovering, developing, manufacturing, and delivering innovative human therapeutics. Currently, AMG 691 is in Phase 1 of its clinical development, with a single trial underway. This initial phase focuses on understanding the drug's safety and how it is processed by the body in a small group of participants.

While Amgen's broader research pipeline has historically included investigations into conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia, AMG 691 represents an expansion of their therapeutic focus. The current Phase 1 study is specifically exploring AMG 691 for its potential in treating mild-to-moderate asthma, indicating a strategic move into new areas of unmet medical need. The progress of AMG 691 from its first trial reflects Amgen's ongoing efforts to advance new treatments through rigorous scientific evaluation.