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NCT04855565 Clinical Trial

ALY688-SR in Generally Healthy Overweight or Obese Adults

Overweight and Obesity Clinical Trial

Official title:
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04855565
Other study ID # ALY688-SR-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date May 19, 2021
Est. completion date August 3, 2021

Study information
Verified date August 2021
Source Allysta Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date August 3, 2021
Est. primary completion date August 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ALY688-SR
single dose subcutaneous injection

Locations
Country Name City State
Australia Nucleus Network Melbourne Victoria

Sponsors (2)
Lead Sponsor Collaborator
Allysta Pharmaceutical INC Research Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 baseline, pre-intervention through study completion at 16 days
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