Study of ALV-100 for Overweight/Obese Adults
This study is testing a drug called ALV-100 in adults who are overweight or obese, with or without type 2 diabetes. The main goals are to understand how safe ALV-100 is and how well people tolerate it. Some participants will receive ALV-100, while others will receive a placebo (an inactive substance that looks like the study drug). You might be able to join if you are between 18 and 65 years old and have a Body Mass Index (BMI) between 27.0 and 39.9 kg/m2. The study is looking at safety and tolerability for up to 52 weeks after the first dose. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 180 participants. Participants will receive either ALV-100 or a placebo in multiple increasing doses.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and tolerability from the first dose up to Week 52.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07399678
Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Recruiting
PHASE1Ages 18–65InterventionalTreatmentAlveus Therapeutics, Inc.
~180 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:ALV-100Placebo
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over From First Dose to Week 52
Conditions
Where it's being run
2 sites across 2 statesFlorida1
Ohio1
Study leadership
- Karen Tornøe, MD, PhD · STUDY_DIRECTOR · Alveus Therapeutics
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Males with female partners of child-bearing potential must be willing to practice abstinence or must agree to use condom as contraception throughout the duration of the study. This criterion may be waived for male participants who have had a documented successful vasectomy \> 6 months before signing the ICF.
Diagnosis of Type 2 Diabetes for at least 180 days prior to Screening.
Glycemic control managed by diet and exercise alone or by stable treatment with metformin and/or sodium-glucose cotransporter 2 inhibitors (SGLT-2i), with no dose changes within 3 months prior to Screening.
Hemoglobin A1c (HbA1c) between 6.5 % and 9.0% (equivalent to 48-75 mmol/mol), both inclusive, at Screening.
Exclusion
History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below or equal to 500 mg/dL (5.65 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).
History of major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or anxiety disorder).
Lifetime history of a suicide attempt or of any suicidal behavior by endorsement of (answered yes to) any of the items in the suicidal behavior section on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.
Systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg at Screening.
History of or current cardiovascular disease, including but not limited to stable and unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, stroke, clinically significant arrhythmias and conduction disorders or venous thromboembolism.
Fasting plasma glucose (FPG) \> 270 mg/dL (15.0 mmol/L) at Screening.
Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (within1.5 years from Screening) ophthalmologic examination.
Severe neuropathy as judged by the investigator.
Advanced nephropathy (defined as albuminuria ≥ 300 mg/g).
History of severe hypoglycemia or hypoglycemic unawareness as judged by the investigator.
What this trial measures
- Safety and tolerabilityFrom First Dose to Week 52
Incidence of treatment emergent adverse events (TEAEs)