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Active, Not Recruiting

NCT Number: NCT06962280

A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight

The main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 20 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Body Weight Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires Macula S.A, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have type 1 diabetes and on insulin treatment for at least one year prior to screening
  • Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
  • Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
  • Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study

Exclusion criteria

  • Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
  • Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Have had chronic or acute pancreatitis
  • Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 40

Secondary outcomes

  1. Change from Baseline in HbA1c

    Time frame: Baseline, Week 72

  2. Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L)) Inclusive, Per Day

    Time frame: Within 30 days prior to Week 40, Within 30 days prior to Week 72

  3. Change from Baseline in Body Weight

    Time frame: Baseline, Week 40, Week 72

  4. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 40, Week 72

  5. Percentage of Participants with ≥5% Body Weight Reduction

    Time frame: Baseline, Week 40, Week 72

  6. Percentage of Participants with ≥10% Body Weight Reduction

    Time frame: Baseline, Week 40, Week 72

  7. Percentage of Participants with ≥15% Body Weight Reduction

    Time frame: Baseline, Week 40, Week 72

  8. Change from Baseline in Waist Circumference

    Time frame: Baseline, Week 40, Week 72

  9. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 40, Week 72

  10. Percent Change from Baseline in Fasting Triglycerides

    Time frame: Baseline, Week 40, Week 72

  11. Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol

    Time frame: Baseline, Week 40, Week 72

  12. Percent Change from Baseline in Total Daily Insulin Dose

    Time frame: Baseline, Week 40, Week 72

  13. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Baseline, Week 40, Week 72

  14. Change from Baseline in EQ-5D-5L

    Time frame: Baseline, Week 40, Week 72

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Long-Term Safety of Tirzepatide Once Weekly Compared to Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

Acronym: SURPASS-T1D-2

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 8, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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