ClinicalTrials.gg
RecruitingNCT07803744Updated Sep 23, 2026

A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity

A Phase 1 interventional study of Tirzepatide and Acetaminophen in Diabetes Mellitus, Type 1, Overweight and Obesity, sponsored by Eli Lilly and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 74 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company — 4 open to participants now, 6 under way, 4 of them phase 3. Diabetes Mellitus, Type 1 · Eli Lilly and Company.

Planned enrollment
62nd of 71
18 · median 67
Started
2026
with 2 others
Phase 1
32 of 74
2 open now
Registered
74th of 74
by date

Among the 74 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company, this one is the 62nd largest by planned enrollment of the 71 interventional ones that give a count, is one of 3 that started in 2026, is one of 32 in phase 1, and was the 74th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

4 of the 74 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 74 studies in Diabetes Mellitus, Type 1 by Eli Lilly and Company, or all of them as a file.
02

Study summary

The main purpose of this study is to learn more how tirzepatide affects stomach emptying in participants with Type 1 Diabetes Mellitus (T1DM) and overweight or obesity.

Participation in this study will last about 8 weeks, including screening and follow-up.

03

Conditions studied

  • Diabetes Mellitus, Type 1
  • Overweight
  • Obesity
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a diagnosis of type 1 diabetes mellitus (T1DM) and have been treated with insulin for at least 1 year prior to screening
  • Have a (BMI) greater than or equal to 25.0 kilograms per square meter (kg/m2) at screening
  • Are of stable weight, that is a self-reported change of 5 kg or less, for at least 90 days prior to screening

Exclusion criteria

Exclusion Criteria:

  • Participants who have a known gastric emptying abnormality
  • Have undergone weight loss surgery such as gastric bypass (bariatric) surgery or restrictive bariatric surgery
  • Have known allergies or intolerance to acetaminophen, tirzepatide, or glucagon-like peptide-1 (GLP-1) receptor agonists
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Tirzepatide + Acetaminophen

    Participants will receive tirzepatide administered subcutaneously (SC) and acetaminophen administered orally.

    Drug: Tirzepatide · Drug: Acetaminophen

  • Placebo comparator
    Placebo + Acetaminophen

    Participants will receive placebo administered SC and acetaminophen administered orally.

    Drug: Acetaminophen · Drug: Placebo

Interventions

  • Administered SC.

    Also known as: LY3298176

  • DrugAcetaminophen

    Administered orally.

  • DrugPlacebo

    Administered SC.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

  3. PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen

    Time frame: Predose on Day 1 through 36 hours post dose

Secondary outcomes

  1. PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC0-∞) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  2. PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  3. PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

  4. PK: Time of Maximum Observed Drug Concentration (Tmax) of Tirzepatide

    Time frame: Predose on Day 1 through Day 29

07

Study locations

1 of 1 sites recruiting
  • Clinical Pharmacology of Miami
    Miami, Florida 33172, United States
    Recruiting
    • · Contact305-817-2900
    • Angel Lamas · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

Of 98 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 3 months is below that.

Counting every sponsor, half of 153 studies reached it within 12 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartActual
Sep 11, 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07803744
Responsible party
Sponsor
First posted
Sep 4, 2026
Start date
Sep 11, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 23, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tirzepatide

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