ALY688-SR in Generally Healthy Overweight or Obese Adults

Phase 1

Terminated

• Conditions: Overweight and Obesity
• Interventions: Drug: ALY688-SR

• Registration Number: NCT04855565
• Lead Sponsor: Allysta Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Study Start: 2021-05-19
• Status Verified: 2021-08
• Primary Completion: 2021-08-03
• Study Completion: 2021-08-03
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ALY688-SR	ALY688-SR	single dose subcutaneous injection
Matching placebo for ALY688-SR	ALY688-SR	single dose subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Change between pre- and post-intervention safety and tolerability assessments	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

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia