ALY688-SR in Generally Healthy Overweight or Obese Adults

Allysta Pharmaceutical

Status and phase: Terminated; Phase 1

Conditions: Overweight and Obesity

Treatments: Drug: ALY688-SR

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04855565

ALY688-SR-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

8 participants in 2 patient groups, including a placebo group

ALY688-SR

Active Comparator group

Description:

single dose subcutaneous injection

Treatment:

Drug: ALY688-SR

Matching placebo for ALY688-SR

Placebo Comparator group

Description:

single dose subcutaneous injection

Treatment:

Drug: ALY688-SR