L-PHENYLALANYL-2-METHYLALANYL-L-ALFA-GLUTAMYLGLYCYL-L-THREONYL-L-PHENYLALANYL-L-THREONYL-L-SERYL-L-ALFA-ASPARTYL-L-VALYL-L-SERYL-L-LYSYL-L-GLUTAMINYL-L-LEUCYL-L-ALFA-GLUTAMYL-L-ALFA-GLUTAMYL-L-LYSYL-L-ARGINYL-L-VALYL-L-ARGINYL-L-ALFA-GLUTAMYL-L-PHENYLALANYL-L-ISOLEUCYL-L-ALFA-GLUTAMYL-L-TRYPTOPHYL-L-LEUCYL-L-LYSYL-L-GLUTAMINYLGLYCYLGLYCYL-L-PROLYL-L-SERYL-L-SERYLGLYCYL-L-LYSYL-L-PROLYL-L-PROLYL-L-PROLYLGLYCYL-L-LYSYL-N6-[N-(19-CARBOXY-1-OXONONADECYL)-L-GAMMA-GLUTAMYL]-L-LYSINE for Obesity

Inclusion criteria

• {"criterion_text":"-Provision of signed and dated informed consent form (ICF)"}
• {"criterion_text":"-Male or female adults, aged ≥18 years"}
• {"criterion_text":"-Have a BMI at Screening of a.\tBMI ≥30 kg/m2 (may or may not have the weight-related co-morbidities listed below) OR b.\tBMI ≥27.0 kg/m2 to <30.0 kg/m2 must have at least one of the following weight-related co-morbidities either previously diagnosed or diagnosed at Screening: • Hypertension: on stable blood pressure (BP)-lowering medication to treat BP or having systolic BP (SBP) ≥130 mmHg or diastolic BP ≥80 mmHg at Screening • Dyslipidemia: on lipid-lowering medication or having LDL-C ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or HDL-C <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women • Clinical diagnosis of obstructive sleep apnea • Cardiovascular disease (eg, heart failure with New York Heart Association (NYHA) Functional Class I-III, history of ischemic or hemorrhagic stroke or cerebrovascular revascularization procedure [eg, carotid endarterectomy and/or stent], myocardial infarction, coronary artery disease, or peripheral vascular disease)"}
• {"criterion_text":"-In the investigator’s opinion, are well-motivated, capable, and willing to a.\tCCI b.\tSelf-inject study drug (or receive an injection from a trained family member or caregiver if visually impaired or with physical limitations) c.\td. Follow trial procedures for the duration of the trial, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan) and complete required documentation and questionnaires"}

Exclusion criteria

• {"criterion_text":"-Female who is breastfeeding, or who is pregnant at Screening, or prior to randomization on Day 1"}
• {"criterion_text":"-Unwilling or unable to follow contraceptive requirements"}
• {"criterion_text":"-Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI Screat-Scys Combined) (using serum creatinine and serum cystatin-c combined)) at Screening"}
• {"criterion_text":"-Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at Screening. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 3 months prior to Screening"}
• {"criterion_text":"-Poorly controlled hypertension, defined as the following: a.\t Mean seated systolic BP ≥180 mm Hg or mean seated diastolic BP ≥120 mm Hg at Screening"}
• {"criterion_text":"-Diagnosis of any form of diabetes (resolved gestational diabetes is permitted) or HbA1c ≥ 6.5% or fasting glucose >125 mg/dL (≥48 mmol/mol), random glucose ≥200 mg/dL (≥11.1 mmol/L) with classic symptoms of hyperglycemia or history of taking any medications to lower glucose within 90 days before Screening."}

Primary endpoints

• {"endpoint_text":"-Percent change from baseline in body weight at Week 64","definition_or_measurement_approach":"Percent change from baseline in body weight measured at Week 64 (percent change from baseline body weight at Week 64)."}

Secondary endpoints

• {"endpoint_text":"-Change from baseline in body weight (kg) at Week 64","definition_or_measurement_approach":"Change in absolute body weight (kg) from baseline measured at Week 64."}
• {"endpoint_text":"-Occurrence at Week 64 of: •\tCCI % of reduction from baseline body weight •\tCCI% of reduction from baseline body weight •\tCCI % of reduction from baseline body weight •\tO CCI % of reduction from baseline body weight","definition_or_measurement_approach":"Proportion of participants achieving prespecified percentage reductions in body weight from baseline at Week 64 (various thresholds as listed)."}
• {"endpoint_text":"-Change from baseline at Week 64 in: •\tFasting triglycerides (mg/dL) •\tO Non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)","definition_or_measurement_approach":"Change from baseline in fasting triglycerides and non-HDL cholesterol measured at Week 64 (mg/dL)."}
• {"endpoint_text":"-Change from baseline in SBP (mmHg) at Week 64","definition_or_measurement_approach":"Change from baseline in systolic blood pressure (mmHg) measured at Week 64."}
• {"endpoint_text":"-Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64","definition_or_measurement_approach":"Change from baseline in SF-36 physical function domain score measured at Week 64 (patient-reported outcome)."}
• {"endpoint_text":"-Percent change from baseline in body weight at Week 84","definition_or_measurement_approach":"Percent change from baseline in body weight measured at Week 84."}
• {"endpoint_text":"-Change from baseline in body weight (kg) at Week 84","definition_or_measurement_approach":"Change in absolute body weight (kg) from baseline measured at Week 84."}

Methods

• Site-based recruitment via investigator sites/clinics (materials titled e.g. 'K2_Recruitment material_PI-house_PrintLeaflet_Public', 'K2_Recruitment material_Trialmed_PatientLeaflet_Public') — target audience: people with overweight or obesity; country-specific site materials exist (e.g. PI-house materials associated with Poland).
• Printed leaflets and patient leaflets (titles include 'PatientLeaflet', 'PrintLeaflet', 'Leaflet') — target audience: potential participants visiting clinics; country-specific versions present (multiple countries).
• Posters distributed at sites ('Poster' in document titles) — target audience: clinic visitors and patients.
• Social media and social media print ('Post Social Media', 'SocialMediaPrint') — channel: digital/social; target audience: general public/potential participants with overweight or obesity; country-specific variants exist (e.g. PI-house social media materials).
• Website recruitment material ('website' in document titles) — channel: trial or sponsor websites; target audience: potential participants seeking trial information.
• SMS outreach ('SMS Options' in document titles) — channel: SMS messaging to potential participants; target audience: patients/contact lists via vendor; appears in Poland materials.
• GP / site referral letters (GP Letter) and other printed brochures (titles include 'GP Letter', 'Brochure') — channel: primary care engagement; target audience: referring physicians and patients.
• Patient cards and other patient-facing materials ('Patient Card' documents) — channel: handouts given at sites; target audience: enrolled/potential participants.

Spain

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

31

Number Of Participants

85

Poland

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

32

Number Of Participants

216

Bulgaria

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

14

Number Of Participants

63

Germany

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

27

Number Of Participants

120

Hungary

Earliest CTIS Part Ii Submission Date

02-03-2026

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

37

Number Of Participants

105

Romania

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

36

Number Of Participants

90

Slovakia

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

26

Number Of Participants

80

Czechia

Earliest CTIS Part Ii Submission Date

16-03-2026

Latest Decision Or Authorization Date

03-04-2026

Processing Time Days

18

Number Of Participants

135

Primary sponsor

Full Name

Metsera Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Verified Clinical Trials LLC

Responsibilities

Database Registry for Patient Duplication Confirmation Check

Name

Iqvia Biotech LLC

Name

Atreo Inc.

Responsibilities

Randomization and Trial Supply Management _ IPR Module

Name

Altasciences Compagnie Inc.

Responsibilities

PK/ADA Analysis

Name

Primevigilance USA Inc.

Name

Bioclinica Inc.

Responsibilities

DXA Scans (Body Composition)

Name

Worldwide Clinical Trials d.o.o.

Third parties

• {"country":"United States","full_name":"Verified Clinical Trials LLC","duties_or_roles":"Database Registry for Patient Duplication Confirmation Check","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"Randomization and Trial Supply Management _ IPR Module","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK/ADA Analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Participant Reimbursement","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"Umotif Limited","duties_or_roles":"Clin-Ro, ePro, PT Experience, Dosing Diary, SMBG Diary","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"IDMC & Adjudication Committee","organisation_type":"Educational Institution"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"DXA Scans (Body Composition)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}