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New treatment option for Obese or Overweight Healthy Volunteers
Official title A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
ClinicalTrials.gov ID: NCT06845202
What this study is testing
What is ALN-4324?
ALN-4324 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obese or overweight healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to: evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Part A:
- Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2 Part B:
- Is an adult patient with a confirmed diagnosis of T2DM
- Has a hemoglobin A1c (HbA1c) ≥7% to \<10.5%
- Has a BMI of ≥25 kg/m\^2 and \<45 kg/m\^2
You likely can't join if
- Part A:
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection Part B:
- Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i Note: other protocol defined...
See the full eligibility criteria
- Part A:
- Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2 Part B:
- Is an adult patient with a confirmed diagnosis of T2DM
- Has a hemoglobin A1c (HbA1c) ≥7% to \<10.5%
- Has a BMI of ≥25 kg/m\^2 and \<45 kg/m\^2
- Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
- Part A:
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection Part B:
- Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i Note: other protocol defined inclusion/exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Montclair, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Marlton, New Jersey, United States
- Monroe, North Carolina, United States
- Dallas, Texas, United States
- Buenos Aires, Argentina
- San Miguel de Tucumán, Argentina
- Concord, Canada
- Mount Royal, Canada
- Vancouver, Canada
- Santiago, Chile
- Essen, Germany
- Gdansk, Poland
- Tarnów, Poland
- Warsaw, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montclair, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Marlton, New Jersey, United States; Monroe, North Carolina, United States; Dallas, Texas, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.