DelfaGLP-1 Atlas

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CompletedPhase 1Results posted

A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

55

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 30-45

Primary endpoint

•Sleep Metabolic Rate (SMR)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04081337
Org study ID17092
Secondary IDI8F-MC-GPGUEli Lilly and Company

Timeline

Milestones

Study first posted2019-09-09actual
Study start2020-07-09actual
Primary completion2022-05-26actual
Study completion2022-05-26actual
Last update posted2024-02-08actual
Results first posted2024-02-08actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive
•Have a stable body weight in the past 1 month prior to screening
•Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion criteria

•Have undergone gastric bypass or bariatric surgery
•Have a diagnosis of type 2 diabetes
•Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
•Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
•Have any lifetime history of a suicide attempt
•Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening
•Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
9
Weight & body composition
8
Glycemic / diabetes
8
Cardiometabolic biomarkers
5
Other clinical outcomes
2

Weight & body composition

8 endpoints
Secondary/registry result

Change From Baseline to Week 18 in Body Weight (BW)

Time frame:Baseline, Week 18

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilogram (kg)95% CI
Placebo-8.26—
15 mg Tirzepatide-16.73—
LS Mean difference-8.4795% CI-11.04 – -5.90p<0.0001Mixed Models Analysis
Secondary/registry result

Change From Baseline to Week 18 in Body Fat-Free Mass

Time frame:Baseline, Week 18

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-1.64—
15 mg Tirzepatide-5.73—
LS Mean difference-4.0895% CI-5.12 – -3.05p<0.0001Mixed Models Analysis
Secondary/registry result

Change From Baseline to Week 18 in Body Fat Mass

Time frame:Baseline, Week 18

Total fat mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-6.75—
15 mg Tirzepatide-11.83—
LS Mean difference-5.0895% CI-6.93 – -3.22p<0.0001ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Percentage of Body Fat Mass

Time frame:Baseline, Week 18

Total fat mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), Percentage95% CI
Placebo-3.12—
15 mg Tirzepatide-4.26—
LS Mean Difference-1.1495% CI-2.16 – -0.11p0.0304ANCOVA
Secondary/protocol endpoint

Change From Baseline to Week 18 in Body Weight (BW)

Time frame:Baseline, Week 18

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Body Fat-Free Mass

Time frame:Baseline, Week 18

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Body Fat Mass

Time frame:Baseline, Week 18

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Percentage of Body Fat Mass

Time frame:Baseline, Week 18

Total fat mass

percent change from baseline, improvement

Glycemic / diabetes

8 endpoints
Secondary/registry result

Change From Baseline to Week 18 in Fasting Insulin Resistance

Time frame:Baseline, Week 18 during standardized mixed meal tolerance test

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), index95% CI
Placebo-0.37—
15 mg Tirzepatide-0.34—
LS Mean Difference0.0395% CI-0.34 – 0.40p0.8762ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Postprandial Insulin Sensitivity

Time frame:Baseline, Week 18

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), index95% CI
Placebo1.43—
15 mg Tirzepatide4.92—
LS Mean difference3.4995% CI0.79 – 6.19p0.0126ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT

Time frame:Baseline, Week 18

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), millimolar.hour per liter (mmol.h/L)95% CI
Placebo-1.73—
15 mg Tirzepatide-3.00—
LS Mean Difference-1.2695% CI-2.34 – -0.19p0.0222ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of glycosylated hemoglobin95% CI
Placebo-0.04—
15 mg Tirzepatide-0.40—
LS Mean difference-0.3695% CI-0.48 – -0.23p<0.0001ANCOVA
Secondary/protocol endpoint

Change From Baseline to Week 18 in Fasting Insulin Resistance

Time frame:Baseline, Week 18 during standardized mixed meal tolerance test

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Postprandial Insulin Sensitivity

Time frame:Baseline, Week 18

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT

Time frame:Baseline, Week 18

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

5 endpoints
Primary/registry result/low confidence

Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)

Time frame:Baseline, Week 18

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kilocalories per day (kcal/day)95% CI
Placebo-154.36—
15 mg Tirzepatide-134.68—
LS Mean Difference19.6895% CI-50.36 – 89.72p0.5733ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)

Time frame:Baseline, Week 18

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), Ratio95% CI
Placebo0.005—
15 mg Tirzepatide-0.030—
LS Mean Difference-0.03495% CI-0.051 – -0.018p<0.0001ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Sleep RQ

Time frame:Baseline, Week 18

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), ratio95% CI
Placebo-0.001—
15 mg Tirzepatide-0,028—
LS Mean difference-0.02895% CI-0.045 – -0.010p0.0031ANCOVA
Secondary/registry result

Change From Baseline to Week 18 in Lipid Metabolism Parameters

Time frame:Baseline, Week 18

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), millimole hour per liter (mmol.h/L)95% CI
PlaceboTriglyceride-0.69—
VLDL cholesterol-0.32—
HDL cholesterol0.20—
Free fatty acid-0.09—
15 mg TirzepatideTriglyceride-2.52—
VLDL cholesterol-1.16—
HDL cholesterol-0.33—
Free fatty acid0.35—
LS Mean difference-1.8395% CI-2.60 – -1.06p<0.0001ANCOVA

For Triglyceride

LS Mean difference-0.8495% CI-1.19 – -0.48p<0.0001ANCOVA

For VLDL

LS Mean difference-0.5395% CI-1.05 – -0.02p0.0436ANCOVA

For HDL

LS Mean Difference0.4595% CI0.23 – 0.66p0.0002ANCOVA

For Free fatty acid

Secondary/protocol endpoint

Change From Baseline to Week 18 in Lipid Metabolism Parameters

Time frame:Baseline, Week 18

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/registry result/low confidence

Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal

Time frame:Baseline, Week 18

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilocalories (kcal)95% CI
Placebo-58.57—
15 mg Tirzepatide-914.51—
LS Mean Difference-855.9495% CI-1090.87 – -621.02p<0.0001ANCOVA
Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal

Time frame:Baseline, Week 18

change from baseline, improvement

Other (unclassified)

9 endpoints
Primary/protocol endpoint/low confidence

Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)

Time frame:Baseline, Week 18

change from baseline, descriptive

Secondary/registry result/low confidence

Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)

Time frame:Baseline, Week 18

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), kcal/day95% CI
Placebo-296.85—
15 mg Tirzepatide-300.07—
LS Mean Difference-3.2295% CI-102.65 – 96.20p0.9481ANCOVA
Secondary/registry result/low confidence

Change From Baseline to Week 18 in Duration of Periods With RQ<0.80

Time frame:Baseline, Week 18

change from baseline, descriptive

Posted result

GroupValue (least_squares_mean), minute95% CI
Placebo2.55—
15 mg Tirzepatide254.44—
LS Mean difference251.8995% CI119.09 – 384.69p0.0004ANCOVA
Secondary/registry result/low confidence

Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation

Time frame:Baseline, Week 18

change from baseline, descriptive

componentsfat oxidation rate, protein oxidation rate, carbohydrate oxidation rate

Posted result

GroupValue (least_squares_mean), gram/day95% CI
PlaceboAdjusted protein oxidation-0.14—
Adjusted fat oxidation-1.64—
Adjusted carbohydrate oxidation4.23—
15 mg TirzepatideAdjusted protein oxidation-7.00—
Adjusted fat oxidation12.83—
Adjusted carbohydrate oxidation-22.42—
LS Mean difference-6.8795% CI-10.51 – -3.22p0.0005ANCOVA

For Adjusted protein oxidation

LS Mean difference14.4895% CI8.02 – 20.93p<0.0001ANCOVA

For Adjusted fat oxidation

LS Mean difference-26.6495% CI-39.46 – -13.83p0.0001ANCOVA

Adjusted carbohydrate oxidation

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)

Time frame:Baseline, Week 18

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)

Time frame:Baseline, Week 18

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in Sleep RQ

Time frame:Baseline, Week 18

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in Duration of Periods With RQ<0.80

Time frame:Baseline, Week 18

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation

Time frame:Baseline, Week 18

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.