NCT07351058 · Hoffmann-La Roche
A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes
(Enith2)
What this study is about
The purpose of this study is to assess the effectiveness 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).
View original scientific 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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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 least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
- Body mass index (BMI) ≥27.0 kg/m\^2
- History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
Exclusion criteria
- 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 congestive heart failure
- 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
Where
- Guntersville, Alabama
- Tucson, Arizona
- Lake Forest, California
- Long Beach, California
- Montclair, California
- Norco, California
- Rancho Cucamonga, California
- Spring Valley, California
- Washington D.C., District of Columbia
- Clearwater, Florida
- Pembroke Pines, Florida
- Port Orange, Florida
And 21 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations