Obesity and OverweightPhase 1/2NCT06857617
This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity
A Phase 1/2 study testing (Part C) MET097 in people with Obesity and Overweight, run by Metsera, a wholly owned subsidiary of Pfizer at 3 sites in United States.
Trial summary
The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity. The trial will be conducted in three parts. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- (Part C) MET097
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2024to 15 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
- At least 18 years of age but not older than 70 years of age
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
- Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit
Who cannot join
- Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
- Seated blood pressure higher than 160/95 mmHg at the Screening visit
- Elevated resting pulse greater than 100 beats per minute at Screening visit
- Presence of clinically significant ECG abnormalities
- Diagnosis of diabetes (type 1 or type 2)
- Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
- Obesity induced by 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).
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site MET097 23-101-002
Anaheim, California, 92801
Research Site MET097 23-101-003
Cypress, California, 90630
Research Site MET097 23-101-001
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy
The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.
The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.
- Conditions
- Obesity and Overweight
- Being tested
- (Part C) MET097, (Part C) Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Part C) MET097Biological
Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows:
- 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg
- 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg
- 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg
- 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg
- 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg
- 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg
- 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg
- 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg
- Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg
- Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg
(Part C) PlaceboBiological
Participants will receive 13 once-weekly subcutaneous injections of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| (Part C) MET097 | Experimental | Once-weekly subcutaneous injection of MET097 for 13 weeks Receives: Biological: (Part C) MET097 |
| (Part C) Placebo | Placebo comparator | Once-weekly subcutaneous injection of Placebo for 13 weeks Receives: Biological: (Part C) Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part C) Percent change from baseline in body weight at Week 12 (Day 85).
Measured: Day 1 (Week 0) to Day 85 (Week 12)
Secondary outcomes (6)
(Part C) To characterize the maximum observed concentration (Cmax).
Measured: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the time of maximum observed concentration (Tmax).
Measured: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the area under the concentration versus time curve (AUC).
Measured: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the elimination half-life (t1/2).
Measured: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.
Measured: Day 1 (Week 0) to Day 85 (Week 12)
(Part C) Occurrence of TEAEs following the 13th dose.
Measured: Day 85 (Week 12) to Day 160 (Week 31)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Apr 2024
- Primary completion3 Jan 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A (72 participants), Part B (70 participants), Part C (120 participants)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metsera, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857617
- Sponsor's protocol ID
- MET097-23-101
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy
- ClinicalTrials.gov ID
- NCT06857617
- Acronym / sponsor ID
- MET097-23-101
- Conditions
- Obesity and Overweight
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Metsera, a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.
The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET097 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET097 or placebo. In Part C, participants will receive once-weekly doses of MET097 or placebo for 12 weeks, followed by a single dose at 2X or 4X to explore the potential for once-monthly dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part A (72 participants), Part B (70 participants), Part C (120 participants)
| Arm | Type | Receives |
|---|---|---|
| (Part C) MET097 | Experimental | Biological: (Part C) MET097Once-weekly subcutaneous injection of MET097 for 13 weeks |
| (Part C) Placebo | Placebo comparator | Biological: (Part C) PlaceboOnce-weekly subcutaneous injection of Placebo for 13 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
- At least 18 years of age but not older than 70 years of age
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
- Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit
Key exclusion criteria (8 listed)
- Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
- Seated blood pressure higher than 160/95 mmHg at the Screening visit
- Elevated resting pulse greater than 100 beats per minute at Screening visit
- Presence of clinically significant ECG abnormalities
- Diagnosis of diabetes (type 1 or type 2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Part C) MET097Participants will receive 13 once-weekly subcutaneous injections of MET097 as follows: * 12 once-weekly doses of 0.6mg followed by a 13th dose of 1.2mg * 12 once-weekly doses of 0.6mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 1.6 mg * 12 once-weekly doses of 0.8 mg followed by a 13th dose of 3.2 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 2.0 mg * 12 once-weekly doses of 1.0 mg followed by a 13th dose of 4.0 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 2.4 mg * 12 once-weekly doses of 1.2 mg followed by a 13th dose of 4.8 mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 2.4mg * Titration regimen of 0.4mg/0.8mg/1.2mg with 4 doses at each dose-level, followed by a 13th dose of 4.8mg | Biological | (Part C) MET097 |
| (Part C) PlaceboParticipants will receive 13 once-weekly subcutaneous injections of matching placebo | Biological | (Part C) Placebo |
Primary outcome
(Part C) Percent change from baseline in body weight at Week 12 (Day 85).
Time frame: Day 1 (Week 0) to Day 85 (Week 12)
6 secondary outcomes
(Part C) To characterize the maximum observed concentration (Cmax).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the time of maximum observed concentration (Tmax).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the area under the concentration versus time curve (AUC).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) To characterize the elimination half-life (t1/2).
Time frame: Day 1 (Week 0) to Day 160 (Week 31)
(Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.
Time frame: Day 1 (Week 0) to Day 85 (Week 12)
(Part C) Occurrence of TEAEs following the 13th dose.
Time frame: Day 85 (Week 12) to Day 160 (Week 31)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing (Part C) MET097 in people with Obesity and Overweight, run by Metsera, a wholly owned subsidiary of Pfizer at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Part C) Percent change from baseline in body weight at Week 12 (Day 85). (time frame: Day 1 (Week 0) to Day 85 (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.