A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
Recruiting · 40 sites across 23 states
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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…
- •At screening, BMI is at least 30.0 kg/m² (obesity), or BMI is 27.0 to under 30.0 kg/m² with at least one weight-related health problem
- •Has tried to lose weight with diet and exercise at least once but it did not work
- •Can take the study medicine as an injection themselves (or get help from a trained person if they cannot inject due to vision or physical limits)
🚫 You may not be able to join if…
- •Has a history of type 1 diabetes or type 2 diabetes, or has had diabetic ketoacidosis or a hyperosmolar coma state
- •Had major weight change (more than 5 kg) in the 3 months before screening
- •Has obesity caused by other hormone/medical disorders (like Cushing’s syndrome) or certain genetic/syndrome forms of obesity
- •Has had or plans weight-loss surgery (with an exception for liposuction or abdominoplasty done more than 1 year before screening)
- •Has certain stomach or pancreas/gallbladder problems (like severe stomach emptying problems, pancreatitis, or clinically significant gallbladder disease), or poorly controlled high blood pressure
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults with obesity or overweight who have BMI ≥30, or BMI 27–<30 with a related condition (like hypertension or sleep apnea)
- ✓No personal history of type 1 or type 2 diabetes (and no ketoacidosis/hyperosmolar coma history)
- ✓Has tried diet/exercise to lose weight without success
- ✓Not currently using (or recently used) GLP-1 medicines like semaglutide or tirzepatide within the last 6 months
- ✓No recent major heart/brain events, uncontrolled blood pressure, serious unstable psychiatric illness, or major stomach/pancreas/gallbladder problems
- !Some conditions may not be a fit: Type 2 diabetes, Depression, Anxiety
- !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 without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.
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.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07351045 · Locations: Alabama · Arizona · California · Connecticut · Georgia · Hawaii · Illinois · Kentucky · Massachusetts · Minnesota · Mississippi · Missouri · New York · Ohio · Oklahoma · Oregon · Pennsylvania · South Carolina · South Dakota · Tennessee · Texas · New South Wales · South Australia