ALY688-SR in Generally Healthy Overweight or Obese Adults

Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04855565

Enrollment

Registered

2021-04-22

Start date

2021-05-19

Completion date

2021-08-03

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

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.

Interventions

DRUGALY688-SR

single dose subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Site staff treating subjects, subjects themselves and the Investigator will be blinded to the treatments being administered.

Intervention model description

Single dose escalation study

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026