Authorised Therapeutic confirmatory (Phase III) Obesity or Overweight Without Type 2 Diabetes

A clinical study to evaluate the effects of RO7795068 in participants with obesity or overweight without type 2 diabetes.

EU CTIS ID: 2025-523104-71-00

What this study is testing

To evaluate the effect of RO7795068 compared with placebo on weight management with respect to Percent (%) change from baseline in body weight at Week 72

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age ≥ 18 years at the time of signing Informed Consent Form
  • Ability and willingness to comply with all aspects of the protocol including completion of all procedures, study visits, questionnaires, assessments for the duration of the study
  • Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
  • Body mass index (BMI) ≥ 30.0 kg/m2 OR BMI ≥ 27.0 and <30.0 kg/m2 and diagnosed with at least one of the following weight-related comorbidities: – Prediabetes as defined by the 2025 American Diabetes Association (ADA) Standards of Medical Care in Diabetes, i.e., HbA1c 5.7–6.4% (39–47 mmol/mol) or fasting plasma glucose 100–125 mg/dL (5.6–6.9 mmol/L) as determined by laboratory test during screening – Hypertension: defined as current stable use (minimum 4 weeks prior to screening) of blood pressure lowering agents initiated for hypertension, or with systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥ 80 mm Hg during screening – Dyslipidemia: defined as current stable use (minimum 4 weeks prior to screening) of lipid-lowering agents initiated for dyslipidemia, or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) < 40 mg/dL (1.0 mmol/L) for men or HDL < 50 mg/dL (1.3 mmol/L) for women as determined by laboratory test during screening – Obstructive sleep apnea – Weight-related cardiovascular disease (including, but not limited to, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)
  • History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight
  • Agreement to adhere to the contraception requirements

You likely can't join if

  • 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 a cholecystectomy to resolve the problem at least 3 months prior to screening.

The study team makes the final eligibility decision.

Where it's taking place

  • Brazil
  • Taiwan
  • United States
  • India
  • United Kingdom
  • Mexico
  • Canada
  • Korea, Republic of
  • China
  • Australia
  • Japan
  • Argentina

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brazil; Taiwan; United States; India; United Kingdom; Mexico and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.