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ALY688-SR in Generally Healthy Overweight or Obese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855565
Recruitment Status : Terminated (Inability to recruit due to COVID-19 pandemic restrictions)
First Posted : April 22, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
INC Research Australia Pty Ltd
Information provided by (Responsible Party):
Allysta Pharmaceutical

Study Description
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Brief Summary:
First in human study of ALY688-SR administered as a subcutaneous injection

Condition or disease Intervention/treatment Phase
Overweight and Obesity Drug: ALY688-SR Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single dose escalation study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.
Primary Purpose: Treatment
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
Actual Study Start Date : May 19, 2021
Actual Primary Completion Date : August 3, 2021
Actual Study Completion Date : August 3, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ALY688-SR
single dose subcutaneous injection
 Drug: ALY688-SR
single dose subcutaneous injection
Placebo Comparator: Matching placebo for ALY688-SR
single dose subcutaneous injection
 Drug: ALY688-SR
single dose subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Change between pre- and post-intervention safety and tolerability assessments [ Time Frame: baseline, pre-intervention through study completion at 16 days ]
    Incidence of Treatment-Emergent Adverse Events as assessed by lab evaluations, ECG, vital signs and physical examinations


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855565


Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Allysta Pharmaceutical
INC Research Australia Pty Ltd
Investigators
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Principal Investigator: Ben Snyder, MD Nucleus Network
More Information
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Responsible Party: Allysta Pharmaceutical
ClinicalTrials.gov Identifier: NCT04855565    
Other Study ID Numbers: ALY688-SR-101
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight