Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Recruiting · 2 sites across 2 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults of any sex, age 18 to 65, when they sign informed consent
- •Body mass index (BMI) between 27.0 and 39.9 kg/m² at screening (overweight should be from extra body fat, as judged by the investigator)
- •Stable body weight (less than 5.0 kg / 11 lbs self-reported change) within 90 days before screening
- •Females must be surgically sterile or post-menopausal (and if post-menopausal and under 55, need FSH > 40 IU/L at screening)
- •For Part B (people with T2D): T2D for at least 180 days, and HbA1c between 7.0% and 9.0% at screening
🚫 You may not be able to join if…
- •Any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (and other conditions) at the investigator’s discretion (with an exception for conditions related to T2D in Part B)
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or a personal history of nonfamilial medullary thyroid carcinoma
- •Current or past chronic or acute pancreatitis
- •Obesity caused by known endocrinologic disorders (for example Cushing syndrome) or certain genetic/syndromic obesity causes (examples given)
- •High blood pressure (systolic ≥ 140 mm Hg or diastolic ≥ 90 mm Hg) or a history of cardiovascular disease such as heart attack, stroke, angina, heart failure, or certain blood clots
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults 18–65 at consent
- ✓BMI 27.0 to 39.9 kg/m² due to excess body fat
- ✓May be in Part A (no confirmed T2D) or Part B (T2D ≥180 days)
- ✓If in Part B: A1c 7.0% to 9.0% with stable diabetes meds (metformin and/or SGLT-2i) or diet/exercise
- ✓Blood pressure must be below 140/90
- ✓No history of certain major cardiovascular disease, pancreatitis, thyroid/MEN2, or severe psychiatric illness
- !Some conditions may not be a fit: Heart / cardiovascular disease, High cholesterol, Depression, Anxiety
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 10 groups in this study.
What to expect, step by step
· This study lasts about 52 weeks (~12 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 52 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: ALV-100
- Drug: Placebo
Has this treatment been tested before?
This is an early-stage study. The treatment has gone through laboratory and preliminary testing before being studied in people here.
Who's running this study?
Sponsor
Alveus Therapeutics, Inc.
Overseen by Karen Tornøe, MD, PhD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Is it safe? Who makes sure of that?+
This is an early study (Phase 1), focused mostly on safety. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07399678 · Locations: Florida · Ohio