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

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What is this study about?

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.

1 study start

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 weekly treatment

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 study assessments during treatment

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 safety monitoring through week 72

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 end of study at week 72

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny	Bialystok	Poland
Hospital Clinico San Carlos	Madrid	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Ośrodek Badań Klinicznych “METABOLICA” lek. Robert Witek	Tarnow	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz	Szekesfehervar	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
IRCCS Policlinico San Donato	San Donato Milanese	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Isala Klinieken Stichting	Zwolle	The Netherlands
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Azienda Ospedaliera Di Perugia	Perugia	Italy
InnoDiab Forschung GmbH	Essen	Germany
Medizentrum Essen Borbeck	Essen	Germany
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
DRC Kft.	Balatonfured	Hungary
Centrum Medyczne All-Med Badania Kliniczne	Cracow	Poland
Edumed s.r.o.	Nachod	Czechia
MEDICON a.s.	Prague	Czechia
Hospital Nisa Sevilla Aljarafe	Castilleja De La Cuesta	Spain
Hospital Ruber Juan Bravo	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Centre Hospitalier Universitaire Rouen	Rouen	France
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
University Of Debrecen	Debrecen	Hungary
Semmelweis University	Budapest	Hungary
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Centre Hospitalier Universitaire De Nantes	Nantes	France
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
MUDr. Alena Vachova	Ceske Budejovice	Czechia
University Of Szeged	Szeged	Hungary
Hospital Quirón Salud Infanta Luisa	Sevilla	Spain
Clinicly Sp. z o.o.	Opole	Poland
Diabetologische Schwerpunktpraxis Pirna	Pirna	Germany
Medispo s.r.o.	Prague	Czechia
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna	Lublin	Poland
Instituto Medico Quirurgico San Rafael S.A.	A Coruna Galicia	Spain
Azienda Ospedaliero Universitaria Pisana	Pisa	Italy
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari	Bari	Italy
Med-Tima Kft.	Budapest	Hungary
Szatmari-Med Kft.	Budapest	Hungary
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum	Hof	Germany
Ddaawgj saczss	Prague	Czechia
Mllmgaons Myzuflg ghslj	Munich	Germany
Cmphvl Hljgjkyddci Uszdedoqebmsu Dv Dzcbv	Dijon	France
Apaobxpqb Ups	Amsterdam	The Netherlands
Ooanlxzoyseeaatyzbusaatlrr	Aalst	Belgium
Cebapf Hvbzfxtcxad Rravlwag Dhbicabtbabauh	Angers	France
Uzs Kcvyoufka Feamscpnh	Essen	Germany
Swiwahdrpgsqbvogw fqg Dfjyxtmu unr Eocnyqceucsxjwfai Dwt mkdp Wduwqykx Kwpwmqzr	Munster	Germany
Hwhylszm Unwcmrkcvbpvl Mslntxr Dh Vuchqcttvn	Santander	Spain
Elv Zwrxdn	Zamosc	Poland
Aufphrn Uflpq Svnnrukkg Ljclrn Dd Bljnsuu	Bologna	Italy
Ausaunv Oavvndjhsmw Piuk Guptkgvu Xtjng	Bergamo	Italy
Ehmfjov Utjkfatbhoez Mjybjaf Cuxdzlx Ryeegbqnl (iciuqui Mae	Rotterdam	The Netherlands
Uxmdatdjxn Mqmzd Gechgcv Ob Czuwuaboy	Catanzaro	Italy
Zvcjqhu fre klrfphwpd Ficcqjggj	Cologne	Germany
Gbtlsi Uykqqyeohc Funcqqosd	Frankfurt	Germany
Hddojguk Vtid dyzaxctt	Barcelona	Spain
Ibqlyyqlejpa Sfztbfajshjhkhq Pcguumek Lbostbso w dgxmhzhpss kwbqimyctwq Lpz meqt Knebdfzmc Cdiployz	Gdynia	Poland
Pioutydnxhqcr Dw Unkjqx Weimavia Dp Dbqzzpd Dsay Urv Pswz Di Jhdl Ackhif	Hamburg	Germany
Dovnqak sqalfn	Plzen	Czechia

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	24.04.2026
Czechia	Recruiting	24.04.2026
France	Not yet recruiting	24.04.2026
Germany	Recruiting	24.04.2026
Hungary	Recruiting	24.04.2026
Italy	Recruiting	24.04.2026
Poland	Recruiting	24.04.2026
Spain	Recruiting	24.04.2026
The Netherlands	Not yet recruiting	24.04.2026

Trial locations

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.

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 ID:

2025-523104-71-00

Protocol code:

WC45725

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?