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RO7795068 for Weight Loss in Adults With Obesity or Overweight Without Type 2 Diabetes

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying obesity and overweight without type 2 diabetes. The treatment being tested is RO7795068, given once a week as an injection. The purpose of the study is to see how well RO7795068 works and how safe it is compared with placebo.

People in the study are assigned by chance to receive either RO7795068 or placebo, and neither the participants nor the study team know which one is being given. The study lasts for about 72 weeks. During this time, the treatment is given regularly, and the study team checks body weight, general health, and possible side effects. The study also looks at changes in waist size, blood sugar, blood fats, blood pressure, eating habits, and quality of life.

Possible side effects, changes in blood tests, heart tracing results, and other safety checks are monitored throughout the study. The trial is designed to find out whether RO7795068 can help with weight management in adults with obesity or overweight who do not have type 2 diabetes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study start</b>

    After you join the study, you begin a 72-week treatment period. The study is randomized, which means you are assigned by chance to one of the study groups.

    The study is double-blind, which means you do not know whether you are receiving the study medicine or the placebo. A placebo is a treatment with no active medicine.

  2. Step 2

    <b>weekly treatment</b>

    You receive RO7795068 as a solution for injection or you receive placebo.

    The study medicine is given once a week for 72 weeks.

    The source data do not provide a dose amount, so the exact dose cannot be stated.

  3. Step 3

    <b>study assessments during treatment</b>

    During the study, your body weight is measured and compared with your starting weight.

    Your waist size, body mass index (BMI), and waist-to-hip and waist-to-height ratios are checked. BMI is a measure that uses height and weight to estimate body size.

    Blood tests are done to check items such as glucose (sugar in the blood), insulin, cholesterol, triglycerides, free fatty acids, and high-sensitivity c-reactive protein (hsCRP). hsCRP is a blood marker that can show inflammation in the body.

    Your blood pressure is measured, including systolic and diastolic blood pressure. Systolic blood pressure is the top number, and diastolic blood pressure is the bottom number.

    Your physical functioning and quality of life are checked using questionnaires, including SF-36v2 Acute Form and IWQoL-Lite-CT. These are questionnaires about daily physical ability and the impact of weight on daily life.

    Your eating-related symptoms are checked with the CoEQ questionnaire. CoEQ means Control of Eating Questionnaire.

    Your urinary incontinence symptoms are checked with the ICIQ-UI SF questionnaire. ICIQ-UI SF means International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form.

    Your overall changes in health and physical function are checked with PGI-C and PGI-S questionnaires. PGI-C means Patient Global Impression of Change, and PGI-S means Patient Global Impression of Severity/Status.

    Your mood and thoughts are checked with the C-SSRS and PHQ-9. C-SSRS means Columbia-Suicide Severity Rating Scale, and PHQ-9 means Patient Health Questionnaire-9.

  4. Step 4

    <b>safety monitoring through week 72</b>

    You are monitored for adverse events, which are unwanted medical problems that happen during the study.

    The study also checks for serious adverse events, adverse events of special interest, and adverse events that lead to stopping the study medicine.

    Your laboratory values, vital signs, and ecg are checked during the study. An ecg, or electrocardiogram, is a test that records the heart’s electrical activity.

  5. Step 5

    <b>end of study at week 72</b>

    At week 72, the main result is measured by comparing your change in body weight from the start of the study.

    At the same time, the study checks whether you have lost at least 5%, 10%, 15%, 20%, 25%, or 30% of your body weight.

    The study also measures changes in body measurements, blood test results, blood pressure, physical functioning, quality of life, eating-related symptoms, urinary incontinence symptoms, and safety findings at week 72.

Who can join the trial?

9 criteria

  • Be at least 18 years old when signing the informed consent form (the document that explains the study and asks for permission to take part).
  • Be able and willing to follow all parts of the study, including all study visits, tests, questionnaires, and other study procedures for the full length of the study.
  • Be able and willing to take the study drug yourself, or receive the injection from a trained person if you have vision problems or physical limitations.
  • Have a body mass index (BMI) of 30.0 kg/m² or higher, or have a BMI of 27.0 to less than 30.0 kg/m² and at least one weight-related health problem.
  • If your BMI is 27.0 to less than 30.0 kg/m², you must have at least one of these weight-related health problems: prediabetes (blood sugar higher than normal but not diabetes, shown by HbA1c 5.7% to 6.4% or fasting plasma glucose 100 to 125 mg/dL), hypertension (high blood pressure), dyslipidemia (abnormal blood fats such as cholesterol or triglycerides), obstructive sleep apnea (breathing repeatedly stops and starts during sleep), or weight-related cardiovascular disease (heart or blood vessel disease related to weight).
  • For hypertension, you must either be using blood pressure medicine that has been stable for at least 4 weeks before screening, or have a screening blood pressure of at least 130 mm Hg systolic or 80 mm Hg diastolic.
  • For dyslipidemia, you must either be using cholesterol-lowering medicine that has been stable for at least 4 weeks before screening, or have one of the following screening blood test results: LDL 160 mg/dL or higher (the “bad” cholesterol), triglycerides 150 mg/dL or higher (a type of fat in the blood), HDL lower than 40 mg/dL for men, or HDL lower than 50 mg/dL for women (HDL is the “good” cholesterol).
  • Have a history of at least 1 unsuccessful attempt to lose weight using diet and exercise.
  • Agree to follow the study’s contraception requirements (rules for preventing pregnancy during the study).

Who cannot join the trial?

12 criteria

  • People with a history of type 1 diabetes or type 2 diabetes cannot take part. Type 1 diabetes means the body does not make enough insulin, and type 2 diabetes means the body does not use insulin well.
  • People with a history of ketoacidosis or hyperosmolar state/coma cannot take part. Ketoacidosis is a dangerous buildup of acids in the blood, and hyperosmolar state/coma is a severe diabetes-related condition that can cause very high blood sugar and confusion or unconsciousness.
  • People who had gestational diabetes in the past may still join only if they have had no diabetes since then. Gestational diabetes is diabetes that happens during pregnancy.
  • People whose body weight changed by more than 5 kg in the 3 months before screening cannot take part. Screening means the check done before joining the study.
  • People whose obesity is caused by another endocrine disorder cannot take part. An endocrine disorder is a problem with hormone-producing glands, such as Cushing’s syndrome.
  • People with a diagnosed monogenic or syndromic form of obesity cannot take part. Monogenic means caused by a change in one gene, and syndromic means part of a larger condition with other symptoms, such as MC4R deficiency or Prader-Willi syndrome.
  • People who had surgery to treat obesity before, or who are planning such surgery, cannot take part.
  • People who had liposuction or abdominoplasty within the past year cannot take part. Liposuction is surgery to remove fat, and abdominoplasty is surgery to remove extra skin and fat from the belly area.
  • People with a known serious problem with gastric emptying cannot take part. Gastric emptying means how food leaves the stomach; examples include severe gastroparesis or gastric outlet obstruction.
  • People with a history of acute pancreatitis or chronic pancreatitis cannot take part. Pancreatitis means swelling of the pancreas, an organ that helps with digestion and blood sugar control.
  • People with a clinically significant gallbladder disease cannot take part. This means a gallbladder problem important enough to affect health.
  • People who had acute pancreatitis caused by gallstones or a significant gallbladder problem may still join only if they had their gallbladder removed at least 3 months before screening and the problem was resolved.
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Investigated drugs

  • RO7795068

    is the study medicine being tested in this trial. It is given as an injection once a week. The goal of the trial is to see whether it helps people with obesity or overweight lose weight and whether it is safe to use over time.

  • RO7795068 placebo

    is an inactive injection used for comparison. It does not contain the study medicine. It helps researchers compare results fairly so they can tell whether any changes in weight or side effects are really caused by RO7795068.

What is already known about the treatment

RO7795068 - RO7795068 is given as a solution for injection, likely by subcutaneous injection, and in this study it is used once weekly. It is still an investigational medicine in clinical trials and is not yet a standard treatment in routine medical care. It is being studied for weight management in people with obesity or overweight without type 2 diabetes, and it belongs to the class of long-acting peptide medicines that act on appetite and metabolism control pathways. At the molecular level, it is designed to bind to specific body receptors involved in hunger and fullness signals, helping reduce food intake and support weight loss.

Investigated diseases

Obesity - Obesity is a condition in which excess body fat builds up to a level that affects body weight and body shape. It usually develops gradually when energy intake stays higher than energy use over time. The amount of body fat may continue to increase, and body weight can keep rising if the imbalance persists.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523104-71-00Protocol codeWC45725Estimated enrolment2 000 patientsSponsorF. Hoffmann-La Roche AG

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