Efficacy And Safety of MET097 Once Weekly In People With Overweight or Obesity (VESPER-4)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Metsera Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

30 Apr 2026 → ongoing

Decision date (initial)

2026-04-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Metsera. Inc,

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Safety

To demonstrate the superiority of CCI mg once-weekly (QW) MET097, compared with placebo, in percent change from baseline body weight at Week 64

Secondary objectives 7

1. To demonstrate superiority of CCI mg QW MET097, compared with placebo, in change from baseline body weight at Week 64
2. To demonstrate superiority of CCI mg QW MET097, compared with placebo, in reduction from baseline body weight at Week 64 of: CCI
3. To demonstrate superiority of QW MET097 (CCI), compared with placebo, on lipids and lipoproteins at Week 64
4. To demonstrate superiority of QW MET097 (CCI), compared with placebo, in change from baseline systolic blood pressure (SBP) at Week 64
5. To demonstrate superiority of QW MET097 (CCI), compared with placebo, in Patient Reported Outcomes (PROs) for physical functioning at Week 64
6. To demonstrate the superiority of CCI mg QW MET097, compared with placebo, in percent change from baseline body weight at Week 84
7. To demonstrate superiority of CCI mg QW MET097, compared with placebo, in change from baseline body weight at Week 84

Conditions and MedDRA coding

Obesity

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-000029-PIP43-66

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Provision of signed and dated informed consent form (ICF)
2. Male or female adults, aged ≥18 years
3. Have a BMI at Screening of a. BMI ≥30 kg/m2 (may or may not have the weight-related co-morbidities listed below) OR b. BMI ≥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)
4. In the investigator’s opinion, are well-motivated, capable, and willing to a. CCI b. Self-inject study drug (or receive an injection from a trained family member or caregiver if visually impaired or with physical limitations) c. d. 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 6

1. Female who is breastfeeding, or who is pregnant at Screening, or prior to randomization on Day 1
2. Unwilling or unable to follow contraceptive requirements
3. 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
4. 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
5. 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
6. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in body weight at Week 64

Secondary endpoints 7

1. Change from baseline in body weight (kg) at Week 64
2. Occurrence at Week 64 of: • CCI % of reduction from baseline body weight • CCI% of reduction from baseline body weight • CCI % of reduction from baseline body weight • O CCI % of reduction from baseline body weight
3. Change from baseline at Week 64 in: • Fasting triglycerides (mg/dL) • O Non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)
4. Change from baseline in SBP (mmHg) at Week 64
5. Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64
6. Percent change from baseline in body weight at Week 84
7. Change from baseline in body weight (kg) at Week 84

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Metsera Inc.

Sponsor organisation

Metsera Inc.

Address

175 Greenwich Street, 3 World Trade Center 3 World Trade Center

City

New York

Postcode

10007-2439

Country

United States

Scientific contact point

Organisation

Metsera Inc.

Contact name

Clinical trial information desk

Public contact point

Organisation

Metsera Inc.

Contact name

Clinical trial information desk

Third parties 11

Locations

8 EU/EEA countries · 125 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 97 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications