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

ConditionsDiabetes Mellitus, Type 1OverweightObesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 body mass index (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

Disqualifiers

Participants who have a known clinically significant 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Administered SC.

  • Acetaminophen

    Drug

    Administered orally.

  • Placebo

    Drug

    Administered SC.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Tirzepatide + AcetaminophenExperimental treatment 2 interventions
Group B: Placebo + AcetaminophenPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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