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Obesity and Obesity-related Medical ConditionsPhase 1/2NCT06924320

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

A Phase 1/2 study testing MET233 and MET097 and MET097 in people with Obesity and Obesity-related Medical Conditions, 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

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
MET233 and MET097 and MET097
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
1 siteUnited States
Study dates
6 Mar 2025to 29 Sep 2026
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
  • BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts G.
  • Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
  • Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
  • Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and/or dyslipidemia.
  • Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and/or a clinical diagnosis of sleep apnea.
  • Willing and able to comply with all scheduled study visits, procedures, and required assessments.
  • Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.

Who cannot join

  • Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.
  • Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
  • Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
  • Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
  • Estimated glomerular filtration rate (eGFR) <80 mL/min at the Screening visit.
  • Diagnosis of Type 1 diabetes.
Show all 17Show fewer
  • For Part A, Part B, Part D, Part E and Part G: Diagnosis of T2DM or glycated hemoglobin (HbA1c) > 6.4% or fasting plasma glucose >126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
  • For Part A, Part B and Part D: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
  • Use of prohibited prescription or non-prescription medications, supplements, or investigational products within protocol-defined washout periods.
  • History or presence of clinically significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases, except where explicitly permitted by the protocol.
  • Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.
  • History of acute or chronic pancreatitis or pancreatic cancer.
  • Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.
  • History of bariatric or weight-loss surgery.
  • Clinically significant psychiatric illness that may interfere with study participation or safety.
  • Screening assessments indicative of moderate to severe depression.
  • History of drug or alcohol abuse or dependence within the past 2 years.

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 PHASE 1/2A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MET233 CO-ADMINISTERED WITH MET097 IN ADULT PARTICIPANTS WITH OBESITY OR OVERWEIGHT INCLUDING PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

Read the detailed description

This is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of MET233 co-administered with MET097 in adult participants with a BMI of 27 to 45 kg/m2 (inclusive), including some participants with T2DM. For Part A, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. For Part B and Part C, after the up to 4-week screening period, the study includes 12 once-weekly doses and an approximately 11-week safety follow-up after the last administration. Parts A and B will include only participants with overweight or obesity without type 2 diabetes. Part C will include participants with overweight or obesity who also have type 2 diabetes. For Part D, after the up to 4-week screening period, the study includes weekly and monthly (ie, every 4 weeks [QM]) and an approximate 11-week safety follow-up after last administration. For Part E, after the up to 4-week screening period, the study includes multiple dose QW-to-QM and an approximate 11-week safety followup after last administration. For Part G, after the up to 4-week screening period, the study includes multiple dose cohort of QW and QM and an approximate 11-week safety followup after last administration.

Being tested
MET233 and MET097, Placebo, MET097
Keywords
GLP-1
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MET233 and MET097Drug

    For subcutaneous administration

  • PlaceboOther

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

  • MET097Drug

    For subcutaneous administration

Study groups in NCT06924320
Study groupRoleWhat they receive
Part A CohortExperimentalCohort participants will receive single co-administered ascending dose (SAD) of subcutaneous (SC) MET233 and SC MET097 or matched SC placebo.
Receives: Drug: MET233 and MET097; Other: Placebo
Part B CohortExperimentalCohort Participants will receive multiple ascending dose (MAD) of co-administered SC MET233 with SC MET097 or matched SC placebo.
Receives: Drug: MET233 and MET097; Other: Placebo
Part C CohortExperimentalCohort Participants will receive multiple doses of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with T2DM.
Receives: Drug: MET233 and MET097; Other: Placebo
Part D CohortExperimentalCohort Participants will receive multiple doses of weekly and monthly (ie, every 4 weeks [QM]) co-administered SC MET233 with SC MET097, or matched SC placebo in participants with obesity.
Receives: Drug: MET233 and MET097; Other: Placebo
Part E CohortExperimentalCohort Participants will receive multiple dose QW-to-QM of SC MET233 co-administered with SC MET097 or matched SC placebo in participants with obesity.
Receives: Drug: MET233 and MET097; Other: Placebo
Part G CohortExperimentalCohort Participants will receive multiple dose cohort of QW and QM SC MET097 monotherapy or matched SC placebo in participants with obesity or overweight.
Receives: Other: Placebo; Drug: MET097

What is being measured

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

  1. Occurrence of treatment-emergent adverse events (TEAEs)

    For Part A, B, C, D, E and G

    Measured: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

Secondary outcomes (17)

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

    For Part A

    Measured: Part A (Baseline, Day 85)

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

    For Part B, C, D, E, and G

    Measured: Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

  3. Minimum observed concentration (Cmin)

    For Part B, C, D, E, and G

    Measured: Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

  4. Maximum observed concentration (Cmax)

    For Part A, B, C, D, E, and G

    Measured: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

  5. Time to maximum observed concentration (Tmax)

    For Part A, B, C, D, E, and G

    Measured: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

  6. Part A: Percent change from baseline in body weight at Day 8

    For Part A

    Measured: Baseline, Day 8

  7. Part A: Percent change from baseline in body weight at all other postbaseline weight measurements

    For Part A

    Measured: Part A (Baseline, Day 85)

  8. Part B and Part C: Percent change from baseline in body weight at Day 85

    Measured: Baseline, Day 85

  9. Part B and Part C: Percent change from baseline in body weight at all other postbaseline weight measurements

    Measured: Part B and Part C (Baseline, Day 155)

  10. Percent change from baseline in body weight at Day 113

    Part B (Cohorts B4-B6) and Part C

    Measured: Baseline, Day 113

  11. Percent change from baseline in body weight at all other postbaseline weight measurements

    Part B (Cohorts B4-B6) and Part C

    Measured: Part B and Part C (Baseline through Day 155)

  12. Percent change from baseline in body weight at Day 113, Day 141 and after QM dosing regimen complete

    For Part D

    Measured: Part D (Baseline, Day 113, Day 141 and Day 169)

  13. Percent change from baseline in body weight at all other postbaseline weight measurements

    Part D

    Measured: Part D (Baseline through Day 218)

  14. Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete

    For Part E

    Measured: Part E (Baseline, Day 141 and Day 197)

  15. Percent change from baseline in body weight at all other postbaseline weight measurements

    For Part E

    Measured: Part E (Baseline through Day 246)

  16. Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete

    For Part G

    Measured: Part G (Baseline, Day 113 and Day 225)

  17. Percent change from baseline in body weight at all other postbaseline weight measurements

    For Part G

    Measured: Part G (Baseline through Day 274)

Timeline

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

  1. First posted11 Apr 2025
  2. Study start6 Mar 2025
  3. Primary completion29 Sep 2026
  4. Study completion29 Sep 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06924320
Sponsor's protocol ID
MET233/097-24-101
Other IDs
C6511001
Status last verified
Oct 2026
First submitted
3 Apr 2025
Last updated
2 Nov 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 1/2 study testing MET233 and MET097 and MET097 in people with Obesity and Obesity-related Medical Conditions, 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 8 inclusion and 17 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 2 Nov 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. 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?

Occurrence of treatment-emergent adverse events (TEAEs) (time frame: Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)). 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 NCT06924320, 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 2 Nov 2026.

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