RecruitingPhase 1NCT07399678

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


Sponsor

Alveus Therapeutics, Inc.

Enrollment

180 participants

Start Date

Dec 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This early-stage study is testing a new investigational drug called ALV-100 in overweight or obese adults, with or without type 2 diabetes, to evaluate whether it is safe and how the body absorbs and uses it. The goal is to understand the drug's safety profile and early effects on blood sugar and body weight before larger trials are conducted. **You may be eligible if...** - You are between 18 and 65 years old - You have a BMI between 27 and 39.9 (overweight or obese) - Your body weight has been stable (within 5 kg) over the past 3 months - If female, you must not be able to become pregnant (surgically sterile or postmenopausal) **You may NOT be eligible if...** - You have type 1 diabetes or are on insulin - You have had recent significant weight loss through surgery or medication - You have serious heart, kidney, or liver disease - You have a recent history of eating disorders - You are pregnant, breastfeeding, or able to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALV-100

Participants will receive multiple ascending doses of ALV-100.

DRUGPlacebo

Participants will receive placebo matching ALV-100, volume-matched to active dose.


Locations(1)

Clinical Pharmacology of Miami

Miami, Florida, United States

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NCT07399678


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