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
Alveus Therapeutics, Inc.
Summary
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For Part A and B * Adult male and female participants, aged 18 to 65 years, inclusive, at the time of signing the informed consent form * Body mass index between 27.0 to 39.9 kg/m2 at Screening, both inclusive; overweight should be due to excess adipose tissue, as judged by the Investigator. * Have a stable body weight (\< 5.0 kg/11 lbs self-reported change) within 90 days prior to Screening * Females must be surgically sterile (by means of bilateral salpingectomy, hysterectomy or bilateral oophorectomy) or be post-menopausal (defined as spontaneous cessation of menses fo…
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.
Location
- Clinical Pharmacology of MiamiMiami, Florida