BridgeMD
Tests treatment safety and results for Overweight or Obese Adults
Official title Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
ClinicalTrials.gov ID: NCT07399678
What this study is testing
What is ALV-100?
ALV-100 is an investigational medicine, being studied as a potential treatment for overweight or obese adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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...
You likely can't join if
- For Part A and B
- History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however screening total cholesterol below or equal to...
- Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of...
- 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...
- History of major depressive disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or anxiety disorder).
See the full eligibility 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 for at least 1 year prior to 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...
- 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.
- For Part A and B
- 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...
- 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...
- History or clinical evidence of Type 1 or Type 2 diabetes mellitus, including HbA1c ≥ 6.5% and/or a fasting plasma glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) at Screening (female participants with a history of gestational...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.