ALY688-SR in Generally Healthy Overweight or Obese Adults

NCT ID: NCT04855565

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2021-08-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single dose escalation study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.

Study Groups

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ALY688-SR

single dose subcutaneous injection

Group Type ACTIVE_COMPARATOR

ALY688-SR

Intervention Type DRUG

single dose subcutaneous injection

Matching placebo for ALY688-SR

single dose subcutaneous injection

Group Type PLACEBO_COMPARATOR

ALY688-SR

Intervention Type DRUG

single dose subcutaneous injection

Interventions

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ALY688-SR

single dose subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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INC Research Australia Pty Ltd

UNKNOWN

Sponsor Role collaborator

Allysta Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Snyder, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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ALY688-SR-101

Identifier Type: -

Identifier Source: org_study_id

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