RecruitingPhase 3

A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well different doses of enicepatide (RO7795068) help with weight loss and how safe they are. It compares the drug with a placebo, which has no active drug. It is for people with obesity or overweight who also have type 2 diabetes.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can and will inject the study drug yourself, or get help from a trained person if vision or physical limits prevent this.
  • Have type 2 diabetes and an HbA1c of 6.5% to 10% at screening. HbA1c measures average blood sugar.
  • Manage diabetes with diet and exercise alone or allowed diabetes pills. Any pill treatment must be stable for at least 3 months before screening; DPP-4 inhibitors and GLP-1-based drugs are not allowed.
  • Have a body mass index (BMI) of at least 27. BMI is a measure of weight compared with height.
  • Have tried at least once to lose weight through diet or exercise without success.

Who can't join

  • Have ever had type 1 diabetes or ketoacidosis (dangerous acid buildup in the blood), or had a severe high-blood-sugar state or coma in the past 12 months.
  • Had severe low blood sugar or could not sense low blood sugar in the past 6 months; or have fasting blood sugar above 270 mg/dL on two separate, non-back-to-back days during screening.
  • Report a weight change of more than 5 kg (about 11 pounds) in the 3 months before screening.
  • Have obesity caused by another hormone disorder or certain genetic conditions.
  • Have had or plan to have weight-loss surgery. Liposuction or a tummy tuck is allowed if done more than 1 year before screening.
  • Have a serious problem with food leaving the stomach, or poorly controlled high blood pressure at screening.
  • Had a heart attack, stroke, mini-stroke, unstable chest pain from heart disease, or a hospital stay for heart failure in the 3 months before screening.
  • Used any approved or experimental GLP-1-based drug in the 6 months before being assigned to a study group.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (45)

AL

AZ

CA

DC

FL

GA

ID

IL

LA

MD

MO

MS

NC

OH

OK

PA

SC

SD

TX

VA

WA