NCT04855565

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

April 16, 2021

Last Update Submit

August 25, 2021

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ALY688-SR

ACTIVE COMPARATOR

single dose subcutaneous injection

Drug: ALY688-SR

Matching placebo for ALY688-SR

PLACEBO COMPARATOR

single dose subcutaneous injection

Drug: ALY688-SR

Interventions

ALY688-SRDRUG

single dose subcutaneous injection

ALY688-SRMatching placebo for ALY688-SR

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,

You may not qualify if:

  • Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ben Snyder, MD

    Nucleus Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Single dose escalation study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 22, 2021

Study Start

May 19, 2021

Primary Completion

August 3, 2021

Study Completion

August 3, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)