What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ALN-2232, Placebo, or Tirzepatide. The registry lists allocation as randomized. This study wants to: * measure the safety, tolerability, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity
They plan to enroll about 156 people at Mount Royal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity
Interventions: ALN-2232, Placebo, Tirzepatide
Primary outcome (registry wording): Part A: Frequency of Adverse Events (AEs)