A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese… (NCT06845202) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
United States, Argentina, Canada144 participantsStarted 2025-03-03
Plain-language summary
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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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)
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 1/2 and is primarily measuring how often adverse events — meaning side effects or bad reactions — occur, what does that mean for how much is already known about whether ALN-4324 is safe, and how would you weigh that uncertainty for someone in my situation?
2The study has two parts — one for overweight or obese healthy volunteers and one for overweight or obese people with Type 2 diabetes — can you help me understand which part I might be considered for, and how my current health profile fits the study's requirements?
3Given that the main thing being tracked in both parts is the frequency of adverse events rather than weight loss or blood sugar improvement, is it realistic to expect a direct treatment benefit from participating, or is this more about helping researchers understand safety at this stage?
4Are there existing approved treatments for obesity or Type 2 diabetes that I should consider first, and how does pursuing a Phase 1/2 trial like this fit into an overall treatment plan alongside those options?
5Since the trial is actively recruiting right now, what would the time commitment and visit schedule actually look like for me, and are there any aspects of the study design — like injections, monitoring, or dietary requirements — that I should know about before deciding whether to discuss enrollment with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.