NCT07399678

Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALV-100 in Participants With Overweight or Obesity With or Without Type 2 Diabetes

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Alveus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes

Conditions

• Overweight or Obese Adults
• Overweight or Obese, Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	ALV-100	Participants will receive multiple ascending doses of ALV-100.
DRUG	Placebo	Participants will receive placebo matching ALV-100, volume-matched to active dose.

Timeline

• Start date: 2025-12-29
• Primary completion: 2027-04-01
• Completion: 2027-09-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study