Back to resultsALY688-SR in Generally Healthy Overweight or Obese Adults
Primary Purpose
Overweight and Obesity
Status
Terminated
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ALY688-SR
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Nucleus Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ALY688-SR
Matching placebo for ALY688-SR
Arm Description
single dose subcutaneous injection
single dose subcutaneous injection
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04855565
First Posted
April 16, 2021
Last Updated
August 25, 2021
Sponsor
Allysta Pharmaceutical
Collaborators
INC Research Australia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04855565
Brief Title
ALY688-SR in Generally Healthy Overweight or Obese Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Inability to recruit due to COVID-19 pandemic restrictions
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allysta Pharmaceutical
Collaborators
INC Research Australia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
First in human study of ALY688-SR administered as a subcutaneous injection
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Single dose escalation study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALY688-SR
Arm Type
Active Comparator
Arm Description
single dose subcutaneous injection
Arm Title
Matching placebo for ALY688-SR
Arm Type
Placebo Comparator
Arm Description
single dose subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
ALY688-SR
Intervention Description
single dose subcutaneous injection
Primary Outcome Measure Information:
Title
Change between pre- and post-intervention safety and tolerability assessments
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Snyder, MD
Organizational Affiliation
Nucleus Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus Network
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ALY688-SR in Generally Healthy Overweight or Obese Adults
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