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ObesityPhase 2NCT06373146

A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

A Phase 2 study testing Tirzepatide and Mibavademab in people with Obesity, run by Eli Lilly and Company at 17 sites 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 main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Tirzepatide and Mibavademab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
392 participants
Where
17 sitesUnited States
Study dates
24 Apr 2024to 2 Apr 2026
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m²
  • Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention)
  • Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Who cannot join

  • Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change (increase or decrease) in body weight >5 kilogram (kg) within 3 months prior to screening
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2
  • Have acute or chronic hepatitis
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Velocity Clinical Research, Gardena

    Gardena, California, 90247

  • Juno Research

    Houston, Texas, 77040

  • Irvine Clinical Research

    Irvine, California, 92614

  • Velocity Clinical Research, Los Angeles

    Los Angeles, California, 90017

  • Hassman Research Institute Marlton Site

    Marlton, New Jersey, 08053

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Velocity Clinical Research - New Orleans

    New Orleans, Louisiana, 70119

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California, 92704

  • Velocity Clinical Research, Panorama City

    Van Nuys, California, 91405

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of Once-Weekly Tirzepatide Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.

Conditions
Obesity
Being tested
Tirzepatide, Mibavademab, Tirzepatide-Placebo, Mibavademab-Placebo
Keywords
Glucagon-like peptide-1 (GLP-1), Leptin, Incretin, Weight maintenance
Medical subject headings
Obesity

What participants receive

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

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • MibavademabDrug

    Also called REGN4461

    Administered SC

  • Tirzepatide-PlaceboDrug

    Administered SC

  • Mibavademab-PlaceboDrug

    Administered SC

Study groups in NCT06373146
Study groupRoleWhat they receive
Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]ExperimentalParticipants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24.
Receives: Drug: Tirzepatide; Drug: Mibavademab
TZP + Mibavademab-placebo (MIBA-PBO) [Group B]ExperimentalParticipants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24.
Receives: Drug: Tirzepatide; Drug: Mibavademab-Placebo
TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]ExperimentalParticipants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
Receives: Drug: Tirzepatide; Drug: Mibavademab; Drug: Tirzepatide-Placebo
TZP + MIBA [Group D]ExperimentalParticipants will receive TZP SC + MIBA SC for 48 weeks.
Receives: Drug: Tirzepatide; Drug: Mibavademab
TZP + MIBA-PBO [Group E]ExperimentalParticipants will receive TZP SC + MIBA-PBO SC for 48 weeks.
Receives: Drug: Tirzepatide; Drug: Mibavademab-Placebo
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]ExperimentalParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
Receives: Drug: Tirzepatide; Drug: Mibavademab; Drug: Tirzepatide-Placebo; Drug: Mibavademab-Placebo
TZP + MIBA-PBO then TZP + MIBA [Group G]ExperimentalParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
Receives: Drug: Tirzepatide; Drug: Mibavademab; Drug: Mibavademab-Placebo
TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]ExperimentalParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
Receives: Drug: Tirzepatide; Drug: Tirzepatide-Placebo; Drug: Mibavademab-Placebo

What is being measured

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

  1. Mean Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 48

Secondary outcomes (13)

  1. Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg)

    Measured: Baseline, Week 24

  2. Mean Absolute Change from Baseline for Body Weight (kg)

    Measured: Baseline, Week 48

  3. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Measured: Baseline to Week 48

  4. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Measured: Baseline to Week 48

  5. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Measured: Baseline to Week 48

  6. Percentage of Participants Who Achieve ≥20 Body Weight Reduction

    Measured: Baseline to Week 48

  7. Mean Percent Change from Randomization 2 for Body Weight

    Measured: Week 24, Week 48

  8. Mean Change from Randomization 2 for Body Weight (kg)

    Measured: Week 24, Week 48

  9. Mean Absolute Change from Randomization 2 for Body Weight (kg)

    Measured: Week 24, Week 48

  10. Change from Baseline to Week 24 in CoEQ Scores

    Measured: Baseline, Week 24

  11. Change from Baseline to Week 48 in CoEQ Scores

    Measured: Baseline, Week 48

  12. Change from Baseline in FCQ-T-r Scores

    Measured: Baseline, Week 24

  13. Change from Baseline in FCQ-T-r Scores

    Measured: Baseline, Week 48

Timeline

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

  1. First posted18 Apr 2024
  2. Study start24 Apr 2024
  3. Primary completion15 Dec 2025
  4. Study completion2 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
392 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373146
Sponsor's protocol ID
18750
Other IDs
I8F-MC-GPIV
Status last verified
May 2026
First submitted
16 Apr 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide and Mibavademab in people with Obesity, run by Eli Lilly and Company at 17 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 3 inclusion and 5 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 6 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 17 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. 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 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?

Mean Percent Change from Baseline in Body Weight (time frame: Baseline, Week 48). 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 NCT06373146.

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 6 May 2026.

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