RO7795068 for Weight Loss in Adults With Obesity or Overweight and Type 2 Diabetes

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Erlangen AöR Erlangen Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Semmelweis University Budapest Hungary
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nice Nice France
University Of Szeged Szeged Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Virgen De La Victoria Malaga Spain
Consultmed S.R.L. Iasi Romania
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Prague Czechia
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
ClinDiab Kft. Budapest Hungary
Fledip s.r.o. Prague Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Centre Hospitalier Saint Joseph Saint Luc Lyon France
Centrum Medyczne Omedica Jaroslaw Opiela I Beata Opiela Sp. j. Poznan Poland
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Azienda Ospedaliera Di Perugia Perugia Italy
InnoDiab Forschung GmbH Essen Germany
Lukmed 2 Sp. z o.o. Siedlce Poland
Nicodiab S.R.L. Bucharest Romania
Area Sanitaria De Ferrol Ferrol Spain
Medizentrum Essen Borbeck Essen Germany
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
DRC Kft. Balatonfured Hungary
Diabetologische Schwerpunktpraxis Pirna Pirna Germany
Med-Tima Kft. Budapest Hungary
MVZ Diabeteszentrum Dr. Tews GmbH Gelnhausen Germany
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari Bari Italy
Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga Stasinska sp.p. Lekarzy Wroclaw Poland
Mesut Durmaz Schwerpunktpraxis für Diabetes, Hormone & Stoffwechsel Studienzentrum Hof Germany
Interni, Diabetologicka a Obezitologicka Ambulance Jesenice Czechia
Hewoohao Vlen duorejjp Barcelona Spain
Hfzakhev Unmexqpcsqbvn df A Cgfyci A Coruna Galicia Spain
Adkioqqati Pmwwwlsb Hlxczeln Dn Mhunbadfr Marseille France
Cimhwu Hrjvlonwsdx Ropydmir Uygokxozumypw Dm Tqnsk Tours France
Axrpfpr Ualtn Sxjalfwym Lnnwaf Db Bvlcczo Bologna Italy
Ayqydzi Ojzzkhvjxlj Pwuv Gxnvqmrr Xbukj Bergamo Italy
Ueeqeevtrl Dcxej Senxz Df Rdho Lw Scserehz Rome Italy
Cwkwqeq Mgjmusb Dl Dwrewnlyfk Sx Teeyjtrel Anoychqnl Nssoik Snazbb Brasov Romania
Ebenkc Sua z osuq Lublin Poland
Iyidewpfq fko Clcqhwqx aob Epepgcqccvnd Micejeqa Prague Czechia
Ebwywqq Pmgrtlsjl Srn z obuv Pabianice Poland
Tee Dtrmwt Sjcqzg Craiova Romania
Pajbxgrgzrqok Di Ukpnwy Wpiszupo Dg Dqxiqfp Dshg Uam Pfkh Dv Juax Aemaxf Hamburg Germany
Elq Luczdd Lublin Poland
Pkzzrghox Inlfmwyj Mhxzjawk Mahekzzznuba Smeyn Wxgycilhclod I Aweoiymzukzvh Warsaw Poland
Geatdz Ucoapyytyw Fnxchplhx Frankfurt Germany
Dizftub Djm Pgjownq Ascymxnikyd Sxjbxy Ploiesti Romania
Uqmorcputn Mfyhb Gnptcfj Od Crvlawuge Catanzaro Italy
Umj Knwjyuohg Fmwqkkpdb Essen Germany
Srolpmtiuveqfjjdx fll Daliymlt ujw Ehjexhtzblaqletmk Dkj mkos Wdgxkrxv Kiulayxu Munster Germany
Hawvhhqd Uankwheqkqdfr Hcuhfuat Tfoou y Pehpss Ipkbcqni Culkdf dhjodooszqofrkmcv (tqpe Badalona Spain
Zcflpyq fau kzvrpjxgx Fpxmfnpab Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
30.04.2026
France France
Recruiting
30.04.2026
Germany Germany
Recruiting
30.04.2026
Hungary Hungary
Not yet recruiting
30.04.2026
Italy Italy
Recruiting
30.04.2026
Poland Poland
Recruiting
30.04.2026
Romania Romania
Recruiting
30.04.2026
Spain Spain
Recruiting
30.04.2026

Trial locations

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.

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 ID:
2025-523106-32-00
Protocol code:
WC45726
Trial Phase:
Therapeutic confirmatory (Phase III)

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