Health TrialsbyHealthPanel

A Study to Evaluate ALN-6222 in Participants With Obesity

ConditionObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlnylam Pharmaceuticals

About this trial

This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is an adult patient with a body mass index ≥30 kg/m² to <40 kg/m²

Has a hemoglobin A1c <6.5%

Disqualifiers

Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)

Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m² at screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-6222

    Drug

    ALN-6222 will be administered subcutaneously (SC).

  • Placebo

    Drug

    Placebo will be administered SC.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: ALN-6222Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of Adverse Events

Time frame
Up to 12 months

Secondary outcomes

1

Concentrations of ALN-6222 in Plasma

Time frame
Predose and up to 3 days postdose
2

Change from Baseline Protein Markers in Plasma

Time frame
Predose and up to 12 months postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alnylam Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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