ALY688-SR in Generally Healthy Overweight or Obese Adults

Phase 1TerminatedNCT04855565

Allysta Pharmaceutical8 enrolled

Overview

First in human study of ALY688-SR administered as a subcutaneous injection

The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overweight and Obesity

Interventions

ALY688-SRDRUG

single dose subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg, Exclusion Criteria: * Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia

Locations (1)

Nucleus Network

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Change between pre- and post-intervention safety and tolerability assessments

Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations

Time frame: baseline, pre-intervention through study completion at 16 days

Data from ClinicalTrials.gov

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