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New treatment option for Obesity or Overweight
Official title A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
ClinicalTrials.gov ID: NCT07351058
What this study is testing
What is Enicepatide?
Enicepatide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity or overweight.
Also referred to as RO7795068, CT-388.
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 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).
- 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
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical...
- Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10%...
- Body mass index (BMI) ≥27.0 kg/m\^2
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
You likely can't join if
- History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to...
- Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
- At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
- 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.
See the full eligibility criteria
- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
- Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at...
- Body mass index (BMI) ≥27.0 kg/m\^2
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
- History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
- Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
- At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
- 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)
- Poorly controlled hypertension at screening
- Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to...
- 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's taking place
- Guntersville, Alabama, United States
- Tucson, Arizona, United States
- Lake Forest, California, United States
- Long Beach, California, United States
- Montclair, California, United States
- Norco, California, United States
- Rancho Cucamonga, California, United States
- Spring Valley, California, United States
- Washington D.C., District of Columbia, United States
- Clearwater, Florida, United States
- Pembroke Pines, Florida, United States
- Port Orange, Florida, United States
- St. Petersburg, Florida, United States
- Columbus, Georgia, United States
- Union City, Georgia, United States
- Lake Charles, Louisiana, United States
- New Orleans, Louisiana, United States
- Columbia, Maryland, United States
- Morehead City, North Carolina, United States
- Columbus, Ohio, United States
+ 123 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 - 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?
Study sites include Guntersville, Alabama, United States; Tucson, Arizona, United States; Lake Forest, California, United States; Long Beach, California, United States; Montclair, California, United States; Norco, California, United States and 137 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.