N-[2-(3-CYANO-5-FLUOROPHENYL)-2-METHYL-1-OXOPROPYL]-BETA-ALANYL-L-ALPHA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALPHA-ASPARTYL-L-TYROSYL-L-SERYL-L-ISOLEUCYL-2-METHYLALANYL-L-LEUCYL-L-ALPHA-ASPARTYL-L-LYSYL-L-ISOLEUCYL-L-ALANYL-L-GLUTAMINYL-N6-[N-(19-CARBOXY-1-OXONONADECYL)-L-GAMMA-GLUTAMYL-2-[2-(2-AMINOETHOXY)ETHOXY]ACETYL-2-[2-(2-AMINOETHOXY)ETHOXY]ACETYL]-L-LYSYL-L-ALANYL-L-PHENYLALANYL-L-VALYL-L-GLUTAMINYL-L-TRYPTOPHYL-L-LEUCYL-L-ISOLEUCYL-L-ALANYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-ALANYL-L-PROLYL-L-PROLYL-L-PROLYL-L-SERINAMIDE for Obesity | Overweight | Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years at the time of signing Informed Consent Form\n- 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\n- Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)\n- BMI ≥27.0 kg/m²\n- Diagnosis of T2DM according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral AHM (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.\n- History of ≥ 1 self-reported unsuccessful diet/exercise effort to lose body weight"}

Exclusion criteria

• {"criterion_text":"- History of Type 1 Diabetes Mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening\n- At least 2 confirmed fasting BG values >270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening\n- Self-reported change in body weight >5 kg within 3 months prior to screening\n- 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)\n- Prior or planned surgical treatment for obesity Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.\n- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)"}

Primary endpoints

• {"endpoint_text":"- Percent (%) change from baseline in body weight at Week 72","definition_or_measurement_approach":"Percent change from baseline in body weight at Week 72 (measured as percent change from baseline body weight to body weight at Week 72)."}

Secondary endpoints

• {"endpoint_text":"- Achieve ≥5% body weight loss at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants achieving ≥5% body weight loss at Week 72 (Yes/No)."}
• {"endpoint_text":"- Achieve ≥10% body weight loss at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants achieving ≥10% body weight loss at Week 72 (Yes/No)."}
• {"endpoint_text":"- Achieve ≥15% body weight loss at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants achieving ≥15% body weight loss at Week 72 (Yes/No)."}
• {"endpoint_text":"- Change from baseline in body weight (kg) at Week 72","definition_or_measurement_approach":"Absolute change in body weight (kg) from baseline to Week 72."}
• {"endpoint_text":"- Change from baseline in HbA1c at Week 72","definition_or_measurement_approach":"Change in hemoglobin A1c (HbA1c) from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Achieve HbA1c of ≤ 6.5% at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants with HbA1c ≤ 6.5% at Week 72 (Yes/No)."}
• {"endpoint_text":"- Achieve HbA1c of <7% at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants with HbA1c < 7% at Week 72 (Yes/No)."}
• {"endpoint_text":"- Change from baseline in waist circumference (cm) at Week 72","definition_or_measurement_approach":"Change in waist circumference (cm) from baseline to Week 72."}
• {"endpoint_text":"- Change from baseline in fasting glucose at Week 72","definition_or_measurement_approach":"Change in fasting plasma glucose from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in fasting insulin at Week 72","definition_or_measurement_approach":"Change in fasting insulin from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in LDL cholesterol at Week 72","definition_or_measurement_approach":"Change in LDL cholesterol from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in HDL cholesterol at Week 72","definition_or_measurement_approach":"Change in HDL cholesterol from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in triglyceride at Week 72","definition_or_measurement_approach":"Change in triglycerides from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in systolic blood pressure at Week 72","definition_or_measurement_approach":"Change in systolic blood pressure from baseline to Week 72 measured by standardized blood pressure measurement."}
• {"endpoint_text":"- Change from baseline in physical functioning as assessed by physical functioning domain of Short Form (36) Health Survey Version 2 Acute Form (SF-36v2 Acute Form) at Week 72","definition_or_measurement_approach":"Change from baseline in the SF-36v2 Acute Form physical functioning domain score at Week 72."}
• {"endpoint_text":"- Change from baseline in physical functioning composite as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) at Week 72","definition_or_measurement_approach":"Change from baseline in the IWQoL-Lite-CT physical functioning composite score at Week 72."}
• {"endpoint_text":"- Change from baseline in waist-to-hip ratio at Week 72","definition_or_measurement_approach":"Change in waist-to-hip ratio from baseline to Week 72."}
• {"endpoint_text":"- Change from baseline in waist-to-height ratio at Week 72","definition_or_measurement_approach":"Change in waist-to-height ratio from baseline to Week 72."}
• {"endpoint_text":"- Change from baseline in Control of Eating Questionnaire (CoEQ) subscale scores for craving control, positive mood, craving for savory and craving for sweet; and the individual hunger item score at Week 72","definition_or_measurement_approach":"Change from baseline to Week 72 in specified CoEQ subscale scores and the individual hunger item score."}
• {"endpoint_text":"- Change from baseline on symptoms and impact of urinary incontinence as assessed by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) at Week 72","definition_or_measurement_approach":"Change from baseline to Week 72 in ICIQ-UI SF total score assessing urinary incontinence symptoms and impact."}
• {"endpoint_text":"- Experience no change, improvement, or worsening in Patient Global Impression of Change (PGI-C) Urinary Incontinence at Week 72","definition_or_measurement_approach":"Participant-reported PGI-C category (no change / improvement / worsening) for urinary incontinence at Week 72 compared with baseline."}
• {"endpoint_text":"- Experience no change, improvement, or worsening in Patient Global Impression of Severity/Status (PGI-S) Urinary Incontinence at Week 72","definition_or_measurement_approach":"Participant-reported PGI-S category (no change / improvement / worsening) for urinary incontinence at Week 72 compared with baseline."}
• {"endpoint_text":"- Experience no change, improvement, or worsening in PGI-C Physical Functioning at Week 72","definition_or_measurement_approach":"Participant-reported PGI-C category for physical functioning at Week 72 compared with baseline."}
• {"endpoint_text":"- Experience no change, improvement, or worsening in PGI-S Physical Functioning at Week 72","definition_or_measurement_approach":"Participant-reported PGI-S category for physical functioning at Week 72 compared with baseline."}
• {"endpoint_text":"- Change from baseline in HRQoL as assessed by SF-36v2 Acute Form domain scores and component summary scores at Week 72","definition_or_measurement_approach":"Change from baseline to Week 72 in SF-36v2 Acute Form domain scores and component summary scores."}
• {"endpoint_text":"- Change from baseline in HRQoL as assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) domain scores and total score at Week 72","definition_or_measurement_approach":"Change from baseline to Week 72 in IWQoL-Lite-CT domain scores and total score."}
• {"endpoint_text":"- Change from baseline at Week 72 in non-HDL cholesterol","definition_or_measurement_approach":"Change in non-HDL cholesterol from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline at Week 72 in VLDL cholesterol","definition_or_measurement_approach":"Change in VLDL cholesterol from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline at Week 72 in total cholesterol","definition_or_measurement_approach":"Change in total cholesterol from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline at Week 72 in free fatty acids","definition_or_measurement_approach":"Change in circulating free fatty acids from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline at Week 72 in diastolic blood pressure","definition_or_measurement_approach":"Change in diastolic blood pressure from baseline to Week 72 measured by standardized blood pressure measurement."}
• {"endpoint_text":"- Change from baseline at Week 72 in high-sensitivity C-reactive protein (hsCRP)","definition_or_measurement_approach":"Change in hsCRP from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Change from baseline in urinary albumin/creatinine ratio at Week 72","definition_or_measurement_approach":"Change in urinary albumin/creatinine ratio from baseline to Week 72 measured by laboratory test."}
• {"endpoint_text":"- Achieve ≥ 15% body weight loss at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants achieving ≥15% body weight loss at Week 72 (Yes/No)."}
• {"endpoint_text":"- Change from baseline in BMI at Week 72","definition_or_measurement_approach":"Change in BMI from baseline to Week 72."}
• {"endpoint_text":"- Percent change from baseline in weight by obesity class, at Week 72","definition_or_measurement_approach":"Percent change in weight from baseline to Week 72 stratified by baseline obesity class."}
• {"endpoint_text":"- Time to achieve ≥5%, ≥10% and ≥15% weight loss from baseline through Week 72 (weeks)","definition_or_measurement_approach":"Time (in weeks) from baseline to first achievement of ≥5%, ≥10%, and ≥15% weight loss up to Week 72."}
• {"endpoint_text":"- Achieve HbA1c of < 5.7% at Week 72 (Yes/No)","definition_or_measurement_approach":"Proportion of participants achieving HbA1c < 5.7% at Week 72 (Yes/No)."}
• {"endpoint_text":"- Incidence and severity of adverse events (AEs) (including SAEs, AESIs and AEs leading to study drug discontinuation), with severity determined according to mild/moderate/severe criteria","definition_or_measurement_approach":"Incidence and severity categorisation (mild/moderate/severe) of AEs including SAEs, AESIs and AEs leading to discontinuation collected throughout the study."}
• {"endpoint_text":"- Change from baseline in selected safety laboratory values, vital signs, and ECGs through Week 72","definition_or_measurement_approach":"Changes from baseline through Week 72 in predefined safety laboratory parameters, vital signs and ECG findings."}
• {"endpoint_text":"- Changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire-9 (PHQ-9) through Week 72","definition_or_measurement_approach":"Change from baseline through Week 72 in C-SSRS and PHQ-9 scores as collected at scheduled visits."}

Methods

• Site-based recruitment via participating hospitals and clinics (endocrinology/diabetology/nutrition departments) in each country (country-specific K1 recruitment arrangements submitted).
• Patient-facing letters sent from sites (Patient Letter PDFs listed).
• Printed materials at sites: study flyers, posters, postcards, brochures (country-specific recruitment materials listed).
• Online recruitment: online ads and study website assets (K2_Recruitment Material_Assests Online Ads and Study Website documents referenced).
• Pre-screening questionnaire to identify potential participants (Pre Screening Questionnaire document referenced).

France

Earliest CTIS Part Ii Submission Date

18-02-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

84

Number Of Sites

5

Number Of Participants

40

Germany

Earliest CTIS Part Ii Submission Date

28-04-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

15

Number Of Sites

12

Number Of Participants

80

Hungary

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

101

Number Of Sites

7

Number Of Participants

64

Italy

Earliest CTIS Part Ii Submission Date

03-02-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

99

Number Of Sites

9

Number Of Participants

73

Spain

Earliest CTIS Part Ii Submission Date

27-04-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

16

Number Of Sites

10

Number Of Participants

80

Poland

Earliest CTIS Part Ii Submission Date

10-04-2026

Latest Decision Or Authorization Date

15-05-2026

Processing Time Days

35

Number Of Sites

10

Number Of Participants

78

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

4g Clinical LLC

Responsibilities

Patient enrollment and IMP assignment

Name

Pra International

Responsibilities

Bioanalytical Lab PK

Name

Pharmaceutical Research Associates Group B.V.

Responsibilities

Bioanalytical Lab ADA

Name

Bioclinica Inc.

Responsibilities

Central Imaging Provider; Clinical outcome assessments PROs / PHQ9 / C-SSRS and eDiary Blood Glucose Monitors and supplies

Name

Labcorp Central Laboratory Services SARL

Responsibilities

Analysis of patient blood samples taken throughout the study

Name

Axon Communications Inc.

Responsibilities

Patient Material- Recruitment/Retention

Third parties

• {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Patient Material- Recruitment/Retention","organisation_type":"Health care"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Patient enrollment and IMP assignment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Analysis of patient blood samples taken throughout the study","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging Provider; Clinical outcome assessements PROs / PHQ9 / C-SSRS and eDiary Blood Glucose Monitors and supplies","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Pra International","duties_or_roles":"Bioanalytical Lab PK","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"Bioanalytical Lab ADA","organisation_type":"Pharmaceutical company"}