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Obesity and OverweightPhase 1NCT07022977

A Study of MET233 in Individuals With Obesity or Overweight

A Phase 1 study testing MET233 in people with Obesity and Overweight, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. 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?
MET233
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
1 siteUnited States
Study dates
6 Nov 2024to 21 Apr 2026
Phase
Phase 1
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

  • Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy.

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences Clinical Los Angeles, Inc.

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 in Otherwise Healthy Adult Participants With Obesity or Overweight

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity.

This study will be conducted in four parts:

  • Part A will evaluate single ascending doses of MET233 or placebo.
  • Part B will evaluate multiple ascending doses, with participants receiving five once-weekly doses of MET233 or placebo.
  • Part C will evaluate once-weekly dosing of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.
  • Part D will evaluate a longer dosing schedule, in which participants will receive twelve once-weekly doses, followed by three monthly doses of MET233 or placebo. Participants in this part will be followed for 14 weeks after the final dose.
Read the detailed description

This is a randomized, placebo-controlled, double-blind study designed to investigate the safety, tolerability, PK and pharmacodynamic (PD) of single and multiple ascending subcutaneous (SC) doses of MET233 in otherwise healthy adult participants with obesity or overweight (body mass index [BMI] 27.0 kg/m2 to 38.0 kg/m2, inclusive for Parts A-C and BMI in Part D 30- 45.0 kg/m2 (inclusive).

  • In Part A, participants will receive a single dose of MET233 at up to five dose levels.
  • In Part B, participants will receive five weekly doses of MET233 at up to four dose levels.
  • In Part C, participants will receive 12 weekly doses of MET233. These doses may include titration. For all cohorts in Part C, a 13th dose administered on Day 85 may be a monthly-equivalent dose to evaluate the potential for switching to a monthly dosing regimen.
  • In Part D, participants will receive 12 once-weekly doses, followed by three monthly doses of MET233 or placebo.
Being tested
MET233, 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.

  • MET233Biological

    For subcutaneous administration

  • PlaceboBiological

    Sterile 0.9% (w/v) saline for subcutaneous administration

Study groups in NCT07022977
Study groupRoleWhat they receive
(Part A) MET233ExperimentalParticipants will receive a single dose of MET233 at up to 5 dose levels
Receives: Biological: MET233
(Part A) PlaceboPlacebo comparatorParticipants will receive a single dose of placebo
Receives: Biological: Placebo
(Part B) MET233ExperimentalParticipants will receive five weekly doses of MET233 at up to 4 dose levels
Receives: Biological: MET233
(Part B) PlaceboPlacebo comparatorParticipants will receive five weekly doses of placebo
Receives: Biological: Placebo
(Part C) MET233ExperimentalParticipants will receive twelve weekly doses of MET233 at up to 4 dose levels, followed by a 13th potential monthly dose
Receives: Biological: MET233
(Part C) PlaceboPlacebo comparatorParticipants will receive twelve weekly doses of placebo, followed by a 13th potential monthly dose
Receives: Biological: Placebo
(Part D) MET233ExperimentalParticipants will receive twelve weekly doses of MET233, followed by three monthly doses.
Receives: Biological: MET233
(Part D) PlaceboPlacebo comparatorParticipants will receive twelve weekly doses of placebo, followed by three monthly doses.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment Emergent Adverse Events

    Measured: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

Secondary outcomes (6)

  1. Area under the concentration versus time curve extrapolated to infinity (AUCinf)

    Measured: Part A (Baseline to Day 85)

  2. Area under the concentration versus time curve during the dosing interval (AUCtau)

    Measured: Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

  3. Maximum observed concentration (Cmax)

    Measured: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

  4. Time to maximum observed concentration (Tmax)

    Measured: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

  5. Elimination half-life (t1/2)

    Measured: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

  6. Percent change from baseline in body weight at the protocol-specified weekly post-baseline measurements

    Measured: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start6 Nov 2024
  3. Primary completion21 Apr 2026
  4. Study completion21 Apr 2026

Resources

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07022977
Sponsor's protocol ID
MET233-24-101
Other IDs
C6501001
Status last verified
May 2026
First submitted
6 Jun 2025
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Bailey CJ, Flatt PR, Conlon JM. Long-acting amylin-related peptides as therapies for obesity and type 2 diabetes. Peptides. 2026 Mar;196:171480. doi: 10.1016/j.peptides.2026.171480. Epub 2026 Feb 24.

    PubMed 41747885

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MET233 in people with Obesity and Overweight, run by Pfizer at 1 site 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 1 inclusion and 7 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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?

Occurrence of Treatment Emergent Adverse Events (time frame: Part A (Baseline to Day 85), Part B (Baseline to Day 113), Part C (Baseline to Day 162), Part D (Baseline to Day 239)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07022977, which also lists 1 linked publication.

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 26 May 2026.

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