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A study testing ALN-4324 for safety and effectiveness in overweight to obese patients with type 2 diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Type 2 Diabetes Mellitus, a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will test a medication called ALN-4324, which will be given as an injection under the skin, and compare it to a placebo. The medication is being tested in people who are overweight or have obesity and also have Type 2 Diabetes Mellitus. Some participants may be taking metformin alone, which is a common diabetes medication, or metformin together with another type of diabetes medication called an SGLT2 inhibitor, such as empagliflozin, dapagliflozin, or canagliflozin. These medications help control blood sugar levels in different ways.

The purpose of this study is to evaluate the safety and how well the body tolerates multiple doses of ALN-4324 in patients with Type 2 Diabetes Mellitus. The study will also look at how effective the medication is in controlling blood sugar and how the body processes the medication. Safety will be checked by monitoring any unwanted effects, measuring vital signs like blood pressure and heart rate, performing heart tests called ECGs, and doing blood tests in the laboratory.

The study is divided into two parts and will involve giving either ALN-4324 or placebo to participants. In one part, healthy volunteers who are overweight or have obesity will receive a single dose, while in the other part, patients with Type 2 Diabetes Mellitus who are overweight or have obesity will receive multiple doses over time. During the study, doctors will measure changes in a blood test called HbA1c, which shows average blood sugar levels over several months, and will also look at how the body responds to sugar by measuring insulin and glucose levels. Blood samples will be taken to measure how much ALN-4324 is in the body. The study will last for several months, and participants will need to attend regular visits for monitoring and testing.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment assignment
Upon joining the study, you will be randomly assigned to receive either ALN-4324 or placebo. A placebo is an inactive substance that looks like the study medication but contains no active ingredient.
Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind design.
The medication will be administered as an injection under the skin, which is called a subcutaneous injection.
Step 2
Multiple dose treatment period
You will receive multiple doses of ALN-4324 or placebo during the study.
Each dose will be given as a subcutaneous injection, meaning the medication is injected under your skin.
The treatment period will last for approximately 6 months.
Step 3
Continuation of current diabetes medications
Throughout the study, you will continue taking your current diabetes medications without any changes.
This includes your metformin medication, which you take at a dose of at least 500 milligrams daily.
If you are also taking an SGLT2 inhibitor medication, such as empagliflozin, dapagliflozin, or canagliflozin, you will continue taking it as prescribed.
SGLT2 inhibitors are medications that help lower blood sugar by causing the kidneys to remove sugar from the body through urine.
Step 4
Regular safety monitoring
During the study, your health will be monitored regularly through various assessments.
Your vital signs will be measured, which include blood pressure, heart rate, breathing rate, and body temperature.
Electrocardiograms, also called ECGs, will be performed to check your heart's electrical activity.
Laboratory tests will be conducted using blood and other samples to assess your overall health and how your body is responding to the treatment.
Step 5
Blood sugar monitoring
Your blood sugar control will be evaluated throughout the study.
At month 6, the change in your HbA1c level from the beginning of the study will be measured. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
You will undergo glucose tolerance tests, which measure how your body processes sugar after you consume a sweet drink.
Additional tests will measure insulin resistance, which indicates how well your body responds to insulin.
Step 6
Blood sample collection for medication levels
Blood samples will be collected at specific times to measure the levels of ALN-4324 and any breakdown products in your bloodstream.
These measurements help determine how the medication moves through and is processed by your body.
Step 7
Thyroid function monitoring
Your thyroid function will be monitored during the study.
The thyroid is a gland in your neck that produces hormones affecting your metabolism and energy levels.
If you take thyroid medication, you will continue taking it at the same dose throughout the study.
Step 8
Study completion
The treatment and monitoring phase of the study is expected to last approximately 6 months.
After completing all scheduled visits and assessments, your participation in the study will end.
The study is estimated to continue recruiting participants until August 2027.

Who can join the trial?

9 criteria

You must be between 18 and 75 years old at the time you agree to join the study.
Your thyroid function (a gland in your neck that controls your body's metabolism) must be stable, meaning no changes in how your thyroid works or in your thyroid medicine doses for the last 4 months.
Your ECG (a test that measures the electrical activity of your heart) must be normal or show no concerning problems. The QTcF (a measurement of your heart rhythm) should be less than 450 milliseconds if you are male or less than 470 milliseconds if you are female.
Your HbA1c (a blood test that shows your average blood sugar levels over the past 2 to 3 months) must be between 7.0% and 10.5%.
Your C-peptide (a substance that shows how much insulin your body makes) must be at or above the normal lower limit.
Your BMI (body mass index, which is a measure of body fat based on height and weight) must be between 25 and 45. If both of your parents are Asian, your BMI must be between 23 and 40.
You must have been diagnosed with Type 2 Diabetes (a condition where your body does not use insulin properly) for at least 6 months before joining the study.
You must be taking one of the following diabetes medicines with no changes in dose or type for at least 3 months before joining, and no changes are expected during the study: Metformin alone (at least 500 mg daily), or Metformin (at least 500 mg daily) combined with one of these SGLT2 inhibitors (medicines that help lower blood sugar by removing sugar through urine): empagliflozin, dapagliflozin, or canagliflozin.
You must be able to understand the study requirements, follow them, and provide written agreement to participate.

Who cannot join the trial?

7 criteria

The specific exclusion criteria (reasons why patients cannot participate) have not been provided in the available study information
Generally, clinical trials for Type 2 Diabetes Mellitus (a condition where the body does not use insulin properly, leading to high blood sugar levels) may exclude patients based on various health and safety factors
Common exclusion factors in diabetes studies may include having other serious medical conditions, taking certain medications that could interfere with the study drug, or having abnormal laboratory test results
Pregnant or breastfeeding women are typically excluded from medication studies to protect the unborn or nursing baby
Patients with severe kidney or liver problems may not be able to participate because these organs help process medications
People with a history of allergic reactions to similar medications might be excluded for safety reasons
Individuals who have participated in another clinical trial recently may need to wait before joining a new study

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
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Medizentrum Essen Borbeck
Essen, Germany
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Studienzentrum Bocholderstrasse
Essen, Germany

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Investigated drugs

ALN-4324
is an investigational medication being studied in this trial. It is being tested to see if it can help people who are overweight or obese and have type 2 diabetes mellitus. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels. This medication is given as an injection and is being evaluated to understand how safe it is, how well it is tolerated by patients, and whether it can help improve their condition. The study will look at what happens in the body after receiving this medication and how it works.
Placebo
is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against ALN-4324 to help researchers understand whether any effects seen are truly due to the active medication or might happen on their own.

ALN-4324

What is already known about the treatment

ALN-4324 – ALN-4324 is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested as a treatment for overweight and obese patients with Type 2 Diabetes Mellitus, a condition where the body cannot properly control blood sugar levels. The medication is administered as an injection, and researchers are evaluating how safe it is, how well it works, and how the body processes it when given in single or multiple doses. The exact way ALN-4324 works at the molecular level to help manage diabetes and weight is still being investigated as part of ongoing research studies.

Investigated diseases

Type 2 Diabetes Mellitus – Type 2 Diabetes Mellitus is a long-term condition that affects how the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or does not produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can build up in the bloodstream because the glucose is not being properly absorbed by the body's cells. The condition typically develops gradually, often over many years, and may go unnoticed in its early stages. As the disease progresses, the body's ability to regulate blood sugar becomes increasingly impaired. This leads to persistently elevated blood sugar levels that can affect various organs and systems throughout the body.