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 | Type 2 diabetes

Inclusion criteria

• {"criterion_text":"- Provision of signed and dated informed consent form (ICF)\n- Male or female adults, aged ≥18 years\n- Have a BMI at Screening of ≥27.0 kg/m2\n- Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria\n- Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with: a. Diet and exercise alone or in combination with • Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin\n- In the investigator’s opinion, are well-motivated, capable, and willing to •\tCCI •\tSelf-inject study drug (or receive an injection from a trained family member or caregiver if visually impaired or with physical limitations) •\tPerform finger stick blood glucose (BG) monitoring, including weekly fasting glucose measurements •\tFollow 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\n- Unwilling or unable to follow contraceptive requirements\n- Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM\n- History of ketoacidosis or hyperosmolar state within 1 year prior to Screening\n- Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening\n- 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\n- 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\n- Poorly controlled hypertension, defined as the following: a. Mean seated systolic BP ≥180 mm Hg or mean seated diastolic BP ≥120 mm Hg at Screening"}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline in body weight at Week 64","definition_or_measurement_approach":"Percent change from baseline 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 body weight (kg) from baseline measured at Week 64."}
• {"endpoint_text":"- Change in HbA1c (%) from baseline at Week 64","definition_or_measurement_approach":"Change in HbA1c (%) from baseline measured at Week 64."}
• {"endpoint_text":"- Occurrence at Week 64 of: o\tCCI % of reduction from baseline body weight o\tCCI % of reduction from baseline body weight o\tCCI % of reduction from baseline body weight o\tCCI % of reduction from baseline body weight","definition_or_measurement_approach":"Proportion of participants achieving predefined percent reductions in body weight from baseline measured at Week 64 (multiple CCI % thresholds as specified in protocol)."}
• {"endpoint_text":"- Change from baseline at Week 64 in: o\tFasting triglycerides (mg/dL) o\tNon-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 body weight measured at Week 84."}
• {"endpoint_text":"- Change from baseline in body weight (kg) at Week 84","definition_or_measurement_approach":"Change in body weight (kg) from baseline measured at Week 84."}
• {"endpoint_text":"- Change in HbA1c (%) from baseline at Week 84","definition_or_measurement_approach":"Change in HbA1c (%) from baseline measured at Week 84."}

Bulgaria

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

20

Number Of Participants

63

Czechia

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

35

Number Of Participants

135

Germany

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

38

Number Of Participants

120

Hungary

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

45

Number Of Participants

105

Romania

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

38

Number Of Participants

90

Spain

Earliest CTIS Part Ii Submission Date

13-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

38

Number Of Participants

85

Poland

Earliest CTIS Part Ii Submission Date

17-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

34

Number Of Participants

241

Slovakia

Earliest CTIS Part Ii Submission Date

17-03-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

30

Number Of Participants

80

Primary sponsor

Full Name

Metsera Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Biotech LLC

Name

Worldwide Clinical Trials d.o.o.

Name

Altasciences Compagnie Inc.

Responsibilities

PK/ADA Analysis

Name

Bioclinica Inc.

Responsibilities

DXA Scans (Body Composition)

Name

Verified Clinical Trials LLC

Responsibilities

Database Registry for Patient Duplication Confirmation Check

Third parties

• {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"Randomization and Trial Supply Management _ IPR Module","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Participant Reimbursement","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Umotif Limited","duties_or_roles":"Clin-Ro, ePro, PT Experience, Dosing Diary, SMBG Diary","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Merative US LP","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"DXA Scans (Body Composition)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK/ADA Analysis","organisation_type":"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":"Verified Clinical Trials LLC","duties_or_roles":"Database Registry for Patient Duplication Confirmation Check","organisation_type":"Pharmaceutical company"}
• {"country":"Croatia","full_name":"Worldwide Clinical Trials d.o.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Multiple (Romania / Spain / Poland / etc.)","full_name":"Futuremeds S.R.L. / Futuremeds Spain S.L. / Futuremeds Sp. z o.o.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility / Pharmaceutical company (local affiliates listed in third parties)"}