Actively Recruiting
Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Led by Alveus Therapeutics, Inc. · Updated on 2026-02-10
180
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
CONDITIONS
Official Title
Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years at the time of consent
- Body mass index between 27.0 and 39.9 kg/m2, with overweight due to excess fat
- Stable body weight within 5.0 kg change in the last 90 days
- Females must be surgically sterile or post-menopausal (no menstruation for at least 1 year), with additional hormone level confirmation if under 55 years
- Males with partners of child-bearing potential must agree to contraception or abstinence during the study, unless vasectomized more than 6 months prior
- For participants with type 2 diabetes: diagnosis at least 180 days before screening
- For participants with type 2 diabetes: blood sugar controlled by diet/exercise or stable metformin and/or SGLT-2 inhibitors with no recent dose changes
- For participants with type 2 diabetes: hemoglobin A1c between 7.0% and 9.0% at screening
You will not qualify if you...
- Clinically relevant respiratory, metabolic (except mild dyslipidemia within specified limits), kidney, liver, gastrointestinal, or endocrine conditions (except those related to type 2 diabetes in Part B)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Current or past pancreatitis
- Obesity caused by known endocrine disorders or genetic/syndromic obesity
- History of major depressive disorder or severe psychiatric disorders such as schizophrenia, bipolar disorder, or anxiety
- Lifetime history of suicide attempt or suicidal behavior per screening scale
- High blood pressure (systolic ≥140 mm Hg or diastolic ≥90 mm Hg)
- History of cardiovascular disease including angina, heart attack, heart failure, stroke, arrhythmias, or blood clots
- For Part A only: history or clinical evidence of diabetes (HbA1c ≥6.5% or fasting glucose ≥126 mg/dL), except gestational diabetes in females
- For Part B only: fasting plasma glucose >270 mg/dL
- For Part B only: severe diabetic eye disease (proliferative retinopathy or maculopathy)
- For Part B only: severe neuropathy
- For Part B only: advanced kidney disease (albuminuria ≥300 mg/g)
- For Part B only: history of severe hypoglycemia or unawareness of hypoglycemia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33172
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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