A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Recruiting
Phase 1
Phase 2
Interventional Study
Obese or Overweight Healthy Volunteers
Type 2 Diabetes Mellitus (T2DM)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 144 (estimated)
- Sponsor
- Alnylam Pharmaceuticals · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 metfor…
Contacts