Obese or Overweight Healthy VolunteersPhase 1/2NCT06845202
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
A Phase 1/2 study testing ALN-4324 in people with Obese or Overweight Healthy Volunteers and Type 2 Diabetes Mellitus (T2DM), run by Alnylam Pharmaceuticals at 22 sites in 6 countries.
Trial 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, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- ALN-4324
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 3 Mar 2025to 31 Aug 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
United States7 sites
Clinical Trial Site
Dallas, Texas, 75230
Clinical Trial Site
Dallas, Texas, 75246
Clinical Trial Site
Marlton, New Jersey, 08053
Clinical Trial Site
Miami, Florida, 33126
Clinical Trial Site
Monroe, North Carolina, 28112
Clinical Trial Site
Montclair, California, 91763
Clinical Trial Site
Washington D.C., District of Columbia, 20009
Argentina4 sites
Clinical Trial Site
Buenos Aires, C1060
Clinical Trial Site
Buenos Aires, C1061AAE
Clinical Trial Site
Buenos Aires, C1061
Clinical Trial Site
San Miguel de Tucumán, T4000IHE
Poland4 sites
Clinical Trial Site
Gdansk, 80-546
Clinical Trial Site
Tarnów, 33-100
Clinical Trial Site
Warsaw, 02-507
Clinical Trial Site
Wroclaw, 51-162
Canada3 sites
Clinical Trial Site
Concord, L4K 4M2
Clinical Trial Site
Mount Royal, H3P 3P1
Clinical Trial Site
Vancouver, V5Y 3W2
Chile3 sites
Clinical Trial Site
Santiago, 7500710
Clinical Trial Site
Santiago, 7770086
Clinical Trial Site
Santiago, 8320000
About this study
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
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, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM
- Being tested
- ALN-4324, Placebo
- Keywords
- siRNA, RNAi therepeutic
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-4324Drug
ALN-4324 will be administered subcutaneously (SC)
PlaceboDrug
Placebo will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: ALN-4324 | Experimental | Participants will be administered a single dose of ALN-4324. Receives: Drug: ALN-4324 |
| Part A: Placebo | Placebo comparator | Participants will be administered a single dose of placebo. Receives: Drug: Placebo |
| Part B: ALN-4324 | Experimental | Participants will be administered multiple doses of ALN-4324 Receives: Drug: ALN-4324 |
| Part B: Placebo | Placebo comparator | Participants will be administered multiple doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Frequency of Adverse Events (AEs)
Measured: Up to 9 months
Part B: Frequency of Adverse Events
Measured: Up to 12 months
Secondary outcomes (7)
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma
Measured: Predose and up to 3 days postdose
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma
Measured: Predose and up to 3 days postdose
Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma
Measured: Predose and up to 3 days postdose
Part A: Fraction of ALN-4324 excreted in urine
Measured: Predose and up to 24 hours postdose (fe)
Part B: Change from Baseline in HbA1c
Measured: Baseline up to 6 months
Part B: Response to Glucose Tolerance Test
Measured: Predose and up to 2 hours postdose
Part B: Concentrations of ALN-4324 in Plasma
Measured: Predose and up to 4 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start3 Mar 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese or Overweight Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845202
- Sponsor's protocol ID
- ALN-4324-001
- Other IDs
- 2024-519005-35-00
- Status last verified
- Oct 2026
- First submitted
- 20 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.