Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlveus Therapeutics, Inc.
About this trial
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Eligibility criteria
Qualifiers
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 for at least 1 year prior to Screening). Females who are post-menopausal and < 55 years must have a follicle-stimulating hormone level > 40 IU/L at Screening.
Disqualifiers
History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however mild dyslipidemia, defined as screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below 300 mg/dL (3.39 mmol/L) is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with type 2 diabetes in Part B) at the discretion of the Investigator.
Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
Current or history of chronic or acute pancreatitis.
Obesity caused by known endocrinologic disorders (e.g., Cushing syndrome) or monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
Trial design
Treatments tested in this trial
- ALV-100
- Placebo
Treatment groups
180 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov