Obesity or Overweight study: Enicepatide
Official title A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes
ClinicalTrials.gov ID: NCT07351045
What this study is testing
What is Enicepatide?
This is an investigational once-weekly injectable medicine being studied for weight management in people with obesity or overweight. It is designed to work by activating two specific hormone receptors in the body, GLP-1 and GIP, which help regulate appetite and blood sugar.
Also referred to as RO7795068, CT-388, RG6640.
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
- The study wants to see if enicepatide is safe and helps people lose weight compared to a placebo. It will test several doses of the drug.
- Who it's for
- It is looking for adults who are overweight or obese and do not have type 2 diabetes, but who have at least one weight‑related health problem.
- What's involved
- Participants will receive either enicepatide or a placebo. They will have regular clinic visits and medical tests to monitor weight and safety.
- Time commitment
- The study lasts several months, with multiple clinic visits for dosing, weight checks, and safety monitoring.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
- BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of...
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical...
You likely can't join if
- History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma.
- Self-reported change in body weight \>5 kg within 3 months prior to screening
- Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g...
- Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- History of acute or chronic pancreatitis or clinically significant gallbladder disease.
See the full eligibility criteria
- Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or
- BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.
- Self-reported change in body weight \>5 kg within 3 months prior to screening
- Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
- Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had...
- Poorly controlled hypertension at screening
- Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina
- Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder).
- Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Anniston, Alabama, United States
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Irvine, California, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- New Haven, Connecticut, United States
- Union City, Georgia, United States
- Honolulu, Hawaii, United States
- Gurnee, Illinois, United States
- Schaumburg, Illinois, United States
- Skokie, Illinois, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Needham, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Gulfport, Mississippi, United States
- Springfield, Missouri, United States
+ 155 more site(s).
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, but 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anniston, Alabama, United States; Birmingham, Alabama, United States; Tucson, Arizona, United States; Irvine, California, United States; San Diego, California, United States; Walnut Creek, California, United States and 169 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.