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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3025876 in Participants With Diabetes

NCTNCT01870297 (opens ClinicalTrials.gov in a new tab)Other id14347Other idI6D-MC-SMRB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
72 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jun 2013
Primary completion
Dec 2014
Completion
Dec 2014
First posted
6 Jun 2013 (estimated)
Last update posted
24 Jan 2019
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    A Study of LY3025876 in Participants With Diabetes

    NCT01870297

    Jun 2013 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).

Interventions

  • LY3025876Drug
  • PlaceboDrug
  • LiraglutideDrug

Arms4

  • Experimental

    LY3025876

    Part A: 0.5 milligram (mg), 1.5 mg, 5 mg, and 15 mg of LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days.

  • Placebo comparator

    Placebo

    Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days

  • Experimental

    LY3025876 + Liraglutide

    Part B: 5.0 mg of LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.

  • Placebo comparator

    Placebo + Liraglutide

    Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame · Predose on Day 1 up to Day 56 in each Part

    Registry description

    A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Secondary outcomes(4)

  1. Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876

    Time frame · Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

    Registry description

    AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model.

  2. PK: Maximum Concentration (Cmax) of LY3025876

    Time frame · Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

  3. Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies

    Time frame · Predose on Day 7, 14, 28, 56, and 180

  4. Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose

    Time frame · Baseline, Day 28

    Registry description

    Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment\*day interaction, and participant as a random effect.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Predose on Day 1 up to Day 56 in each Part

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

GroupValue (participants)
Placebo Part A0
0.5 mg LY30258760
1.5 mg LY30258760
5.0 mg LY30258760
15 mg LY30258760
Placebo + Liraglutide0
5.0 mg LY3025876 + Liraglutide0
Secondary and other outcome results(4)
Secondary outcomeGeometric mean· Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876

GroupValue (nanograms*hour/milliliter (ng*hr/mL))Spread
0.5 mg LY302587651.561.1
1.5 mg LY302587620751.2
5.0 mg LY302587662242.3
15 mg LY3025876193032.4
LY3025876 + Liraglutide52537.8
Secondary outcomeGeometric mean· Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose

PK: Maximum Concentration (Cmax) of LY3025876

GroupValue (nanogram/milliliter (ng/mL))Spread
0.5 mg LY30258763.9033.7
1.5 mg LY302587617.543.7
5.0 mg LY302587645.139.2
15 mg LY302587612644.3
5.0 mg LY3025876 + Liraglutide40.348.3
Secondary outcomeCount of participants· Predose on Day 7, 14, 28, 56, and 180

Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies

GroupValue (Participants)
Placebo Part A0
0.5 mg LY30258760
1.5 mg LY30258760
5.0 mg LY30258760
15 mg LY30258761
Placebo + Liraglutide0
5.0 mg LY3025876 + Liraglutide1
Secondary outcomeLeast squares mean· Baseline, Day 28

Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose

GroupValue (milligram/deciliter (mg/dL))Spread
Placebo Part A3.528.41
0.5 mg LY302587618.0810.02
1.5 mg LY30258760.129.92
5.0 mg LY3025876-14.509.33
15 mg LY302587622.9611.51
Placebo Part B11.725.94
5.0 mg LY3025876 + Liraglutide6.325.64

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo Part APart A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.–0 / 115 / 11
0.5 mg LY3025876Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.–0 / 157 / 15
1.5 mg LY3025876Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.–0 / 88 / 8
5.0 mg LY3025876Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.–0 / 99 / 9
15 mg LY3025876Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.–0 / 1010 / 10
Placebo Part BPart B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days.–0 / 99 / 9
Placebo + LiraglutidePart B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.–0 / 109 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days * Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m\^2) at screening * Have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmHg) (systolic) and 40-95 mmHg (diastolic) * Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause Exclusion Criteria: * Have taken LY3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 \[FGF21\]-related drugs) or have known allergies to these drugs * History or presence of bone disease (including osteoporosis or unhealed fractures) * Current active treatment of periodontal disease * Have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months * Have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma * Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (GLP-1) analogues, or other related compounds * Have a history of acute or chronic pancreatitis * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

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