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Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight

ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHudson Biotech

About this trial

Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years (inclusive) at time of informed consent.

BMI ≥30 and ≤50 kg/m², OR BMI ≥27 and <30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).

Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.

Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).

Disqualifiers

History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma.

Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL).

Self-reported change in body weight >5 kg within 3 months prior to screening.

Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty >1 year prior).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retatrutide (LY3437943)

    Drug

    subcutaneous injection, once weekly (dose per assigned arm).

  • Placebo

    Drug

    subcutaneous injection, once weekly (schedule matched to an active arm).

  • Standardized diet and physical activity counseling throughout the study.

    Behavioral

    Standardized diet and physical activity counseling throughout the study.

Treatment groups

300 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Retatrutide (LY3437943) 1 mg once weekly (no escalation)Experimental treatment 3 interventions
Group B: Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg.Experimental treatment 3 interventions
Group C: Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation).Experimental treatment 3 interventions
Group D: Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mgExperimental treatment 3 interventions
Group E: Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg.Experimental treatment 3 interventions
Group F: Placebo once weekly (matched escalation schedule to maintain blinding).Experimental treatment 3 interventions
Group G: Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Mean percent change in body weight from randomization/baseline to Week 24.

Time frame
24 weeks

Secondary outcomes

1

Mean percent change in body weight from baseline to Week 48

Time frame
48 weeks
2

Proportion of participants achieving ≥5%, ≥10%, and ≥15% body weight reduction at Weeks 24 and 48.

Time frame
48 weeks
3

Mean change in body weight (kg) at Weeks 24 and 48.

Time frame
48 weeks
4

Mean change in BMI (kg/m²) at Weeks 24 and 48.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hudson Biotech

Lead sponsor

Source ClinicalTrials.gov
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