DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06619015

TOTT

WithdrawnPhase 2, PHASE3

Tailoring Obesity Treatment Trial

The Impact of Pramlintide on Top of Semaglutide in Obese People With Prediabetes

Assets

Pramlintide / Semaglutide

Listed sites

1

Recruiting sites

—

Enrollment

—

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoint

•Kilocalorie (kCal) consumption at ad libitum meal test, from baseline

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 IDNCT06619015
Org study ID24/39715
Secondary ID2024-510802-10-00

Timeline

Milestones

Study first posted2024-10-01actual
Study start2025-04-01actual
Primary completion2025-04-01actual
Study completion2025-04-01actual
Last update posted2026-04-17actual

Assets

Investigational agents

PramlintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•BMI ≧ 30kg/m2
•HbA1c 39-47 mmol/mol (pre-diabetes)
•Male or female
•Aged >18 years of age and <70 years
•Negative pregnancy test, and willing to use contraceptives during the study period

Exclusion criteria

•Presence of diabetes with or without treatment
•Current or recent (<6 months) treatment with GLP1 RA's
•Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production
•History of acute or chronic pancreatitis
•Chronic kidney disease
•Use of any antipsychotic drugs
•Use of any antiresorptive or bone-anabolic drugs or fractures within < 6 months
•Use of systemic oral glucocorticoids within < 6 months
•Newly (< 3 months) initiated hormonal contraceptive or other hormone therapy
•Recent (<3 months) weight loss ≧ 1% of body weight
•Presence of Binge eating disorder

Endpoints (8)

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

Weight & body composition
3
Other clinical outcomes
3
Patient-reported / QoL
2

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Difference in total weight loss between the subgroups (Obesity phenotypes)

Time frame:From baseline (week 0) to end of study (week 26)

percent change from baseline, improvement

Secondary/protocol endpoint

Total weight loss

Time frame:From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Total weight loss

Time frame:From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

Body weight, absolute change (kg)

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change in appetite and satiety sensations as measured by Visual Analog Scale (VAS) prior to and following the meal tests

Time frame:From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

change from baseline, improvement

Other/protocol endpoint

Change in hedonic eating behavior as measured by questionnaires

Time frame:From baseline (week 0) to after 24 weeks, and to the end of the study (week 26)

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 26 weeks of semaglutide of which the last two weeks is with the addition of either pramlintide or placebo

Time frame:From baseline at the start of the study(week 0), to the end of the study after 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in gastric emptying rate assessed by paracetamol (acetaminophen) test

Time frame:From baseline (week 0) to end of study(week 26)

change from baseline, descriptive

Other/protocol endpoint

Change in sensory specific desires as measured by a taste test

Time frame:From baseline (week 0) to after 24 weeks, and to the end of the study (week 26)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.