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RO7795068 for Weight Loss in Adults With Obesity or Overweight and 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 study is being done in people with obesity or overweight and type 2 diabetes. It is testing RO7795068, a medicine given once a week by injection, compared with placebo. The purpose of the study is to see how well and how safely RO7795068 helps with weight loss.

The study lasts about 72 weeks. People in the study are placed into different groups by chance, and neither the participants nor the study team know who receives RO7795068 or placebo during the study. Before treatment starts, a first check is done. After that, the medicine is given regularly, and follow-up visits continue through the study period to monitor weight, blood sugar, and overall health.

The study also looks at changes related to HbA1c, a blood test that shows average blood sugar over time, as well as waist size, blood pressure, cholesterol, and possible side effects. It also checks how the treatment may affect daily physical function and quality of life.

The research process

"{\n \"timeline\": [\n {\n \"step\": \"study treatment begins\",\n \"step_number\": \"1\",\n \"details\": [\n \"you start the study after joining it as a participant with obesity or overweight and type 2 diabetes.\",\n \"you are assigned in a randomized way, which means by chance, to receive either RO7795068 or placebo. placebo means a product with no active study medicine.\",\n \"the study is double-blind, which means that you do not know which treatment you receive, and the study team does not know during the study.\",\n \"the study is parallel group, which means that different groups of participants receive different study treatments at the same time.\"\n ]\n },\n {\n \"step\": \"once-weekly injections during the study\",\n \"step_number\": \"2\",\n \"details\": [\n \"you receive RO7795068 as a solution for injection or you receive placebo as the study treatment.\",\n \"the study medicine is given once every week.\",\n \"the planned treatment period lasts until week 72.\",\n \"the main study comparison is based on how your body weight changes from the start of the study to week 72.\"\n ]\n },\n {\n \"step\": \"study checks during the trial\",\n \"step_number\": \"3\",\n \"details\": [\n \"during the study, your body weight is measured and compared with the start of the study.\",\n \"your blood sugar control is checked using HbA1c, which is a blood test that shows average blood sugar over time.\",\n \"other checks include waist size, fasting glucose, fasting insulin, cholesterol, triglycerides, blood pressure, body mass index (BMI), and other blood and urine tests.\",\n \"your heart tracing, called an ecg or electrocardiogram, is also checked.\",\n \"your physical functioning, eating-related symptoms, urinary incontinence, and quality of life are assessed with questionnaires.\",\n \"safety is monitored through reports of side effects, study laboratory tests, vital signs, ecgs, and questions about mood and suicide-related thoughts.\"\n ]\n },\n {\n \"step\": \"week 72 assessment\",\n \"step_number\": \"4\",\n \"details\": [\n \"at week 72, your body weight change from the start of the study is measured as the main result.\",\n \"at the same time, the study checks whether you have lost at least 5%, 10%, or 15% of your body weight.\",\n \"at week 72, the study also checks blood sugar control, blood fats, blood pressure, waist measurements, urine tests, physical functioning, and quality of life.\",\n \"the study records whether you have any side effects, including side effects that are severe or that lead to stopping the study treatment.\"\n ]\n },\n {\n \"step\": \"study end\",\n \"step_number\": \"5\",\n \"details\": [\n \"the trial is planned to continue until the end date of 2028-08-04.\",\n \"the study treatment period and all planned assessments are completed by the end of the trial.\"\n ]\n }\n ]\n}"

Who can join the trial?

8 criteria

  • Be an adult aged 18 years or older when signing the informed consent form, which is the document that gives permission to join the study.
  • Be able and willing to follow all parts of the study, including completing study procedures, visits, questionnaires, and other assessments for the full study period.
  • Be able and willing to give the study treatment to yourself, or receive the injection from a trained person if you have vision problems or physical limitations.
  • Have a body mass index (BMI) of at least 27.0 kg/m². BMI is a number based on height and weight that helps describe body weight.
  • Have type 2 diabetes diagnosed by accepted medical standards, with a blood test at screening showing HbA1c between 6.5% and 10%. HbA1c is a blood test that shows average blood sugar over the past 2 to 3 months.
  • If taking diabetes medicine by mouth, have been on a stable oral treatment for at least 3 months before screening. Stable means the medicine and dose have not changed recently.
  • Have type 2 diabetes managed by diet and exercise alone, or by an allowed oral diabetes medicine. Allowed medicines do not include DPP-4 inhibitors or GLP-1 receptor agonist treatment. These are types of diabetes medicines that work in different ways to lower blood sugar.
  • Have at least one past attempt to lose weight with diet and exercise that did not work, based on your own report.

Who cannot join the trial?

6 criteria

  • A history of type 1 diabetes (a form of diabetes where the body does not make insulin), or any past episode of ketoacidosis (a dangerous buildup of acids in the blood caused by not having enough insulin), or a history of hyperosmolar state/coma (a severe diabetes emergency causing very high blood sugar and confusion or unconsciousness) within the 12 months before screening.
  • At least 2 confirmed fasting blood glucose results above 270 mg/dL (15.0 mmol/L) on 2 different non-consecutive days during screening. Fasting blood glucose means blood sugar measured after not eating for a period of time.
  • A self-reported change in body weight of more than 5 kg within the 3 months before screening.
  • Obesity caused by another endocrine disorder (a hormone problem), such as Cushing’s syndrome, or a diagnosed monogenic or syndromic form of obesity. Monogenic means caused by a change in one gene; syndromic means part of a broader medical syndrome.
  • Previous or planned surgery for weight loss. Liposuction (removal of fat by suction) or abdominoplasty (tummy tuck surgery) is allowed only if it was done more than 1 year before screening.
  • A known medically important problem with gastric emptying (how quickly food leaves the stomach), such as severe gastroparesis (slow stomach emptying) or gastric outlet obstruction (a blockage that prevents food from leaving the stomach).
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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 trial is looking at whether this medicine can help people with obesity or overweight and type 2 diabetes lose weight and improve weight management over time, while also checking its safety.

  • RO7795068 placebo is ignored

    because placebo products are not included in the description list.

What is already known about the treatment

RO7795068 - RO7795068 is given as a solution for injection, used by a once-weekly shot under the skin. It is an investigational medicine in clinical trials and is not yet a standard approved treatment in routine medical care. It is being studied for weight management in people with obesity or overweight and type 2 diabetes, and it likely works by acting on a hormone system that helps control appetite, blood sugar, and how the body uses energy. Pharmacologically, it belongs to the class of long-acting peptide medicines used for metabolic disease.

Investigated diseases

  • Obesity

    Obesity is a long-term condition in which excess body fat builds up to a level that can affect health. It usually develops gradually when energy intake stays higher than energy use over time. The condition can progress with continued weight gain and increasing body size, especially around the abdomen. It may also be linked with changes in blood sugar, blood fats, and blood pressure.

  • Overweight

    Overweight means having more body weight than is considered healthy for a person's height. It often develops slowly and may progress to obesity if excess weight continues to increase. The condition is commonly marked by gradual increases in body mass and waist size. It can be associated with worsening metabolic changes over time.

  • Type 2 Diabetes Mellitus

    Type 2 diabetes mellitus is a chronic disease in which the body does not use insulin properly, leading to high blood sugar levels. It usually develops gradually and may begin with mild blood sugar changes before becoming more noticeable. Over time, blood sugar levels can rise further as the body becomes less responsive to insulin. The condition often progresses alongside weight gain and other metabolic changes.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523106-32-00Protocol codeWC45726Estimated enrolment1 602 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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