A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
Recruiting · 40 sites across 16 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?
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
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…
- •You can give yourself the study injection, or a trained person can help you if you can’t inject yourself.
- •You have type 2 diabetes (T2DM) based on WHO or local rules, with HbA1c from 6.5% to 10% on a screening lab test.
- •You are on stable oral diabetes medicine for at least 3 months before screening (or you may be on diet/exercise alone, if that’s allowed locally).
- •You have a BMI of at least 27.0 kg/m².
- •You have tried to lose weight with diet and exercise at least once but it didn’t work.
🚫 You may not be able to join if…
- •You have type 1 diabetes (T1DM), or you had ketoacidosis or a hyperosmolar state/coma within 12 months before screening.
- •You had severe low blood sugar, or you don’t notice low blood sugar, within 6 months before screening.
- •During screening, you had at least 2 fasting blood glucose results above 270 mg/dL (15.0 mmol/L) on two different non-consecutive days.
- •Your weight changed more than 5 kg within 3 months before screening.
- •You are already on (or recently used) GLP-1-RA-based therapy within 6 months before randomization, or you need a disqualifying stomach-emptying condition or major recent heart/stroke problems.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults with type 2 diabetes (HbA1c 6.5% to 10%)
- ✓BMI 27 or higher
- ✓On stable oral diabetes meds (for at least 3 months if applicable) and not using certain diabetes drug classes
- ✓Tried to lose weight with diet/exercise but were unsuccessful
- ✓Not recently on GLP-1 medicines (or they require a washout before starting)
- !Some conditions may not be a fit: Heart / cardiovascular disease, High blood pressure
- !May require a break from current GLP-1 medications
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 4 groups in this study.
What to expect, step by step
· This study lasts about 72 weeks (~17 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 72 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
- Combination_product: Placebo
- Combination_product: Enicepatide
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
Hoffmann-La Roche
Overseen by Clinical Trials
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. 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.
I take a GLP-1 medication (like Ozempic or Wegovy). Can I still join?+
Maybe. This study may ask you to pause certain weight or diabetes medications for a period of time (a 'washout') before joining, or it may be looking for people not currently on them. The coordinator will review your medications with you — don't stop any medication on your own.
Does it cost anything? Will I be paid?+
Study-related care is 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.
Source: ClinicalTrials.gov · NCT07351058 · Locations: Alabama · Arizona · California · District of Columbia · Florida · Georgia · Louisiana · Maryland · North Carolina · Ohio · Oklahoma · South Carolina · South Dakota · Texas · Virginia · Washington