Health TrialsbyHealthPanel

A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

ConditionsOverweightObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

See Master Protocol CWMM (NCT06143956) for inclusion criteria

Disqualifiers

Have type 1 diabetes or type 2 diabetes

Have an ongoing history of bradyarrhythmia and/or sinus bradycardia

Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)

Have a history of acute or chronic pancreatitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Macupatide

    Drug

    Administered SC

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

400 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Macupatide Dose 1Experimental treatment 1 intervention
Group B: Eloralintide Dose 1Experimental treatment 1 intervention
Group C: Macupatide Dose 1 + Eloralintide Dose 1Experimental treatment 2 interventions
Group D: Eloralintide Dose 2Experimental treatment 1 intervention
Group E: Macupatide Dose 1 + Eloralintide Dose 2Experimental treatment 2 interventions
Group F: Eloralintide Dose 3Experimental treatment 1 intervention
Group G: Macupatide Dose 2 + Eloralintide Dose 3Experimental treatment 2 interventions
Group H: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 36

Secondary outcomes

1

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 48
2

Change from Baseline in Body Weight

Time frame
Baseline, Week 36
3

Percentage of Participants who Achieve ≥5% Body Weight Reduction

Time frame
Week 36
4

Percentage of Participants who Achieve ≥10% Body Weight Reduction

Time frame
Week 36

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
Apply now