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

Part of paid clinical trials in Miami, Florida.

Sponsor
Alveus Therapeutics, Inc.
Study ID
NCT07399678
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 29, 2025
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Cohort 1 (ALV-100)
    Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
  • Placebo Comparator: Part A - Cohort 1 (Placebo)
    Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
  • Experimental: Part A - Cohort 2 (ALV-100)
    Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
  • Placebo Comparator: Part A - Cohort 2 (Placebo)
    Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
  • Experimental: Part A - Cohort 3 (ALV-100)
    Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
  • Placebo Comparator: Part A - Cohort 3 (Placebo)
    Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
  • Experimental: Part A - Cohort 4 (ALV-100)
    Participants with overweight or obesity without type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
  • Placebo Comparator: Part A - Cohort 4 (Placebo)
    Participants with overweight or obesity without type 2 diabetes will receive placebo by subcutaneous injection.
  • Experimental: Part B - T2D Cohort (ALV-100)
    Participants with overweight or obesity with type 2 diabetes will receive ascending doses of ALV-100 by subcutaneous injection.
  • Placebo Comparator: Part B - T2D Cohort (Placebo)
    Participants with overweight or obesity with type 2 diabetes will receive placebo by subcutaneous injection.

Primary Outcome Measure

Safety and tolerability [ Time Frame: From First Dose to Week 52 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of MiamiMiamiFlorida33172-
Ohio Clinical TrialsColumbusOhio43212-

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By research site
Clinical Pharmacology of Miami· Miami, FLOhio Clinical Trials· Columbus, OH

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